Trial Outcomes & Findings for Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714) (NCT NCT00696878)

Results Overview

Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

682 participants

Primary outcome timeframe

Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle

Results posted on

2024-06-18

Participant Flow

To complete study, a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3).

Participant milestones

Participant milestones
Measure	Corifollitropin Alfa 150 µg Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\[rec\]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer (FTET) cycles (up to 3 after each COS cycle) could occur.
Overall Study STARTED	682
Overall Study COMPLETED	178
Overall Study NOT COMPLETED	504

Reasons for withdrawal

Reasons for withdrawal
Measure	Corifollitropin Alfa 150 µg Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\[rec\]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer (FTET) cycles (up to 3 after each COS cycle) could occur.
Overall Study Adverse Event	8
Overall Study Withdrawal by Subject	87
Overall Study Stop Treat Cycle 3 not for Adverse Event	18
Overall Study Pregnant prior to Treat Cycle 3	304
Overall Study Trial stopped	32
Overall Study Other reason (not specified)	55

Baseline Characteristics

Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Age, Continuous	32.9 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	682 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle

Population: Participants who received corifollitropin alfa and had a post dose sample for anti-corifollitropin alfa antibody testing

Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Percentage of Participants With Clinically Relevant Immunogenicity Cycle 1 (n=681)	0.0 percentage of participants
Percentage of Participants With Clinically Relevant Immunogenicity Cycle 2 (n=372)	0.0 percentage of participants
Percentage of Participants With Clinically Relevant Immunogenicity Cycle 3 (n=192)	0.0 percentage of participants

PRIMARY outcome

Timeframe: 30 minutes post dose in each treatment cycle

Population: Participants who received corifollitropin alfa

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles None	679 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles Mild	3 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles Moderate	0 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles Severe	0 participants

PRIMARY outcome

Timeframe: 30 minutes post dose in each treatment cycle

Population: Participants who received corifollitropin alfa

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles None	678 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles Mild	4 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles Moderate	0 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles Severe	0 participants

PRIMARY outcome

Timeframe: 30 minutes post dose in each treatment cycle

Population: Participants who received corifollitropin alfa

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles None	654 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles Mild	28 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles Moderate	0 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles Severe	0 participants

PRIMARY outcome

Timeframe: 30 minutes post dose in each treatment cycle

Population: Participants who received corifollitropin alfa

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles None	680 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles Mild	2 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles Moderate	0 participants
Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles Severe	0 participants

PRIMARY outcome

Timeframe: 30 minutes post dose in each treatment cycle

Population: Participants who received corifollitropin alfa

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles None	647 participants
Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles Mild	35 participants
Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles Moderate	0 participants
Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles Severe	0 participants

PRIMARY outcome

Timeframe: Up to approximately 26 months after first dose of corifollitropin alfa

Population: Participants who received corifollitropin alfa

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With AEs	409 participants

PRIMARY outcome

Timeframe: Up to approximately 26 months after first dose of corifollitropin alfa

Population: Participants who received corifollitropin alfa

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With Serious AEs (SAEs)	51 participants

PRIMARY outcome

Timeframe: Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle

Population: Participants who received corifollitropin alfa

OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size \>10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) Cycle 1 (n=682)	12 participants
Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) Cycle 2 (n=375)	4 participants
Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) Cycle 3 (n=198)	0 participants

SECONDARY outcome

Timeframe: Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle

Population: Participants who received corifollitropin alfa and (rec)hCG

Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=664 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG Cycle 1 (n=658)	400.0 International Unit (IU) Interval 0.0 to 2100.0
Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG Cycle 2 (n=364)	450.0 International Unit (IU) Interval 0.0 to 1950.0
Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG Cycle 3 (n=190)	450.0 International Unit (IU) Interval 0.0 to 2250.0

SECONDARY outcome

Timeframe: Stimulation Day 1 in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 1

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=666 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 follicles ≥11 mm	0.0 follicles Standard Deviation 0.1
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 follicles ≥15 mm	0.0 follicles Standard Deviation 0.1
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 follicles ≥17 mm	0.0 follicles Standard Deviation 0.1

SECONDARY outcome

Timeframe: Stimulation Day 1 in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 2

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=370 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 follicles ≥11 mm	0.0 follicles Standard Deviation 0.3
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 follicles ≥15 mm	0.0 follicles Standard Deviation 0.0
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 follicles ≥17 mm	0.0 follicles Standard Deviation 0.0

SECONDARY outcome

Timeframe: Stimulation Day 1 in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 3

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=196 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3 follicles ≥17 mm	0.0 follicles Standard Deviation 0.0
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3 follicles ≥11 mm	0.0 follicles Standard Deviation 0.2
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3 follicles ≥15 mm	0.0 follicles Standard Deviation 0.0

SECONDARY outcome

Timeframe: Stimulation Day 5 or 6 in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 1

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=677 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1 follicles ≥11 mm	5.1 follicles Standard Deviation 4.2
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1 follicles ≥15 mm	0.4 follicles Standard Deviation 1.0
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1 follicles ≥17 mm	0.1 follicles Standard Deviation 0.3

SECONDARY outcome

Timeframe: Stimulation Day 5 or 6 in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 2

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=372 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2 follicles ≥11 mm	4.8 follicles Standard Deviation 4.1
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2 follicles ≥15 mm	0.4 follicles Standard Deviation 1.0
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2 follicles ≥17 mm	0.1 follicles Standard Deviation 0.4

SECONDARY outcome

Timeframe: Stimulation Day 5 or 6 in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 3

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=198 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3 follicles ≥11 mm	4.0 follicles Standard Deviation 3.3
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3 follicles ≥15 mm	0.3 follicles Standard Deviation 0.9
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3 follicles ≥17 mm	0.0 follicles Standard Deviation 0.3

SECONDARY outcome

Timeframe: Stimulation Day 8 in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 1

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=660 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1 follicles ≥11 mm	11.1 follicles Standard Deviation 5.9
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1 follicles ≥15 mm	3.7 follicles Standard Deviation 3.3
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1 follicles ≥17 mm	1.1 follicles Standard Deviation 1.8

SECONDARY outcome

Timeframe: Stimulation Day 8 in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 2

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=363 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2 follicles ≥11 mm	10.7 follicles Standard Deviation 5.4
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2 follicles ≥15 mm	3.6 follicles Standard Deviation 3.3
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2 follicles ≥17 mm	1.2 follicles Standard Deviation 1.8

SECONDARY outcome

Timeframe: Stimulation Day 8 in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 3

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=194 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3 follicles ≥11 mm	10.0 follicles Standard Deviation 5.8
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3 follicles ≥15 mm	3.4 follicles Standard Deviation 3.3
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3 follicles ≥17 mm	1.1 follicles Standard Deviation 1.8

SECONDARY outcome

Timeframe: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 1

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=640 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1 follicles ≥15 mm	9.2 follicles Standard Deviation 4.3
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1 follicles ≥17 mm	5.4 follicles Standard Deviation 2.8
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1 follicles ≥11 mm	14.5 follicles Standard Deviation 6.4

SECONDARY outcome

Timeframe: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 2

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=359 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2 follicles ≥11 mm	13.9 follicles Standard Deviation 6.0
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2 follicles ≥15 mm	9.0 follicles Standard Deviation 3.9
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2 follicles ≥17 mm	5.4 follicles Standard Deviation 2.7

SECONDARY outcome

Timeframe: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 3

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=185 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3 follicles ≥11 mm	13.7 follicles Standard Deviation 6.4
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3 follicles ≥15 mm	9.0 follicles Standard Deviation 4.7
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3 follicles ≥17 mm	5.4 follicles Standard Deviation 2.9

SECONDARY outcome

Timeframe: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle

Population: Participants who received corifollitropin alfa

Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Oocytes Retrieved in a Participant Among Entire Study Population Cycle 1 (n=682)	11.9 number of oocytes Standard Deviation 7.2
Number of Oocytes Retrieved in a Participant Among Entire Study Population Cycle 2 (n=375)	11.5 number of oocytes Standard Deviation 6.8
Number of Oocytes Retrieved in a Participant Among Entire Study Population Cycle 3 (n=198)	11.3 number of oocytes Standard Deviation 7.6

SECONDARY outcome

Timeframe: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 1

This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=462 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 Metaphase II	9.8 number of oocytes Standard Deviation 6.0
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 Oocytes assessed	12.2 number of oocytes Standard Deviation 7.0
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 Metaphase I	0.8 number of oocytes Standard Deviation 1.4
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 Germinal vesicles stage	0.9 number of oocytes Standard Deviation 1.4

SECONDARY outcome

Timeframe: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 2

This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=281 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 Oocytes assessed	11.6 number of oocytes Standard Deviation 6.5
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 Metaphase I	0.9 number of oocytes Standard Deviation 1.5
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 Metaphase II	9.3 number of oocytes Standard Deviation 5.4
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 Germinal vesicles stage	0.8 number of oocytes Standard Deviation 1.4

SECONDARY outcome

Timeframe: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 3

This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=151 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 Oocytes assessed	11.3 number of oocytes Standard Deviation 6.3
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 Metaphase I	0.8 number of oocytes Standard Deviation 1.3
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 Germinal vesicles stage	0.9 number of oocytes Standard Deviation 1.5
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 Metaphase II	9.1 number of oocytes Standard Deviation 5.2

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=649 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained in Treatment Cycle 1 0 PN fertilized oocytes	2.2 number of fertilized oocytes Standard Deviation 2.9
Number of Fertilized Oocytes Obtained in Treatment Cycle 1 1 PN fertilized oocytes	0.2 number of fertilized oocytes Standard Deviation 0.6
Number of Fertilized Oocytes Obtained in Treatment Cycle 1 2 PN fertilized oocytes	6.1 number of fertilized oocytes Standard Deviation 4.0
Number of Fertilized Oocytes Obtained in Treatment Cycle 1 ≥3 PN fertilized oocytes	0.3 number of fertilized oocytes Standard Deviation 0.7
Number of Fertilized Oocytes Obtained in Treatment Cycle 1 Other fertilized oocytes	0.7 number of fertilized oocytes Standard Deviation 1.6

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=359 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained in Treatment Cycle 2 1 PN fertilized oocytes	0.3 number of fertilized oocytes Standard Deviation 0.9
Number of Fertilized Oocytes Obtained in Treatment Cycle 2 2 PN fertilized oocytes	6.1 number of fertilized oocytes Standard Deviation 4.0
Number of Fertilized Oocytes Obtained in Treatment Cycle 2 ≥3 PN fertilized oocytes	0.3 number of fertilized oocytes Standard Deviation 0.7
Number of Fertilized Oocytes Obtained in Treatment Cycle 2 Other fertilized oocytes	0.6 number of fertilized oocytes Standard Deviation 1.2
Number of Fertilized Oocytes Obtained in Treatment Cycle 2 0 PN fertilized oocytes	2.1 number of fertilized oocytes Standard Deviation 2.5

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=188 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained in Treatment Cycle 3 0 PN fertilized oocytes	1.8 number of fertilized oocytes Standard Deviation 2.3
Number of Fertilized Oocytes Obtained in Treatment Cycle 3 1 PN fertilized oocytes	0.2 number of fertilized oocytes Standard Deviation 0.5
Number of Fertilized Oocytes Obtained in Treatment Cycle 3 2 PN fertilized oocytes	6.2 number of fertilized oocytes Standard Deviation 4.2
Number of Fertilized Oocytes Obtained in Treatment Cycle 3 ≥3 PN fertilized oocytes	0.3 number of fertilized oocytes Standard Deviation 0.7
Number of Fertilized Oocytes Obtained in Treatment Cycle 3 Other fertilized oocytes	0.8 number of fertilized oocytes Standard Deviation 1.6

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1, and were enrolled at a site using cyropreservation at the fertilized oocyte level

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=103 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 0 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 1 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.1
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 2 PN fertilized oocytes	1.9 number of fertilized oocytes Standard Deviation 3.2
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 ≥3 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 Other fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2, and were enrolled at a site using cyropreservation at the fertilized oocyte level

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=55 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 0 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 1 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 Other fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 2 PN fertilized oocytes	1.6 number of fertilized oocytes Standard Deviation 3.3
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 ≥3 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3, and were enrolled at a site using cyropreservation at the fertilized oocyte level

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=32 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 0 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 1 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 ≥3 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 Other fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 2 PN fertilized oocytes	1.1 number of fertilized oocytes Standard Deviation 2.1

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=649 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 0 PN fertilized oocytes	0.6 number of fertilized oocytes Standard Deviation 1.9
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 1 PN fertilized oocytes	0.1 number of fertilized oocytes Standard Deviation 0.3
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 2 PN fertilized oocytes	5.7 number of fertilized oocytes Standard Deviation 4.1
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 ≥3 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 Other fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.1

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=359 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 0 PN fertilized oocytes	0.6 number of fertilized oocytes Standard Deviation 1.8
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 1 PN fertilized oocytes	0.1 number of fertilized oocytes Standard Deviation 0.8
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 2 PN fertilized oocytes	5.8 number of fertilized oocytes Standard Deviation 3.9
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 ≥3 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.0
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 Other fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.2

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3

This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=188 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 0 PN fertilized oocytes	0.5 number of fertilized oocytes Standard Deviation 1.6
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 1 PN fertilized oocytes	0.1 number of fertilized oocytes Standard Deviation 0.4
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 2 PN fertilized oocytes	6.0 number of fertilized oocytes Standard Deviation 4.2
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 ≥3 PN fertilized oocytes	0.0 number of fertilized oocytes Standard Deviation 0.1
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 Other fertilized oocytes	0.1 number of fertilized oocytes Standard Deviation 0.6

SECONDARY outcome

Timeframe: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI

The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=659 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Fertilization Rate Cycle 1 (n=649)	67.0 percentage of oocytes Standard Deviation 26.6
Fertilization Rate Cycle 2 (n=359)	66.0 percentage of oocytes Standard Deviation 25.8
Fertilization Rate Cycle 3 (n=188)	67.3 percentage of oocytes Standard Deviation 23.4

SECONDARY outcome

Timeframe: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3

At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=610 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 Good quality (Grade 1 + 2)	3.2 number of embryos Standard Deviation 3.1
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 Grade 1	1.2 number of embryos Standard Deviation 2.1
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 Grade 2	1.9 number of embryos Standard Deviation 2.3
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 Total obtained	6.4 number of embryos Standard Deviation 4.5
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 Grade 3	2.3 number of embryos Standard Deviation 2.5
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 Other grade	1.0 number of embryos Standard Deviation 2.1

SECONDARY outcome

Timeframe: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3

At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=351 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 Grade 1	1.2 number of embryos Standard Deviation 1.9
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 Grade 2	1.8 number of embryos Standard Deviation 2.0
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 Grade 3	2.4 number of embryos Standard Deviation 2.7
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 Other grade	1.2 number of embryos Standard Deviation 2.4
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 Total obtained	6.5 number of embryos Standard Deviation 4.4
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 Good quality (Grade 1 + 2)	2.9 number of embryos Standard Deviation 2.8

SECONDARY outcome

Timeframe: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3

At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=186 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 Total obtained	6.6 number of embryos Standard Deviation 4.8
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 Good quality (Grade 1 + 2)	2.8 number of embryos Standard Deviation 2.7
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 Grade 1	1.0 number of embryos Standard Deviation 1.9
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 Grade 2	1.8 number of embryos Standard Deviation 2.0
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 Grade 3	2.6 number of embryos Standard Deviation 3.0
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 Other grade	1.1 number of embryos Standard Deviation 2.2

SECONDARY outcome

Timeframe: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle

Population: Participants who received corifollitropin alfa and had ET

ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=642 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Embryos Transferred Cycle 2 (n=340)	2.1 number of embryos Standard Deviation 0.7
Number of Embryos Transferred Cycle 3 (n=178)	2.2 number of embryos Standard Deviation 0.7
Number of Embryos Transferred Cycle 1 (n=616)	1.9 number of embryos Standard Deviation 0.7

SECONDARY outcome

Timeframe: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and had ET in Treatment Cycle 1

The number of embryos transferred, for each participant, by category of number of "good quality" embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=616 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 With 0 good quality embryos transferred	110 participants 4.5
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 With 3 good quality embryos transferred	75 participants 2.3
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 With 1 good quality embryo transferred	230 participants 3.1
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 With 2 good quality embryos transferred	201 participants 2.1

SECONDARY outcome

Timeframe: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and had ET in Treatment Cycle 2

The number of embryos transferred, for each participant, by category of number of "good quality" embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=340 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 With 0 good quality embryos transferred	81 participants 4.5
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 With 1 good quality embryo transferred	80 participants 3.1
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 With 2 good quality embryos transferred	122 participants 2.1
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 With 3 good quality embryos transferred	57 participants 2.3

SECONDARY outcome

Timeframe: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and had ET in Treatment Cycle 3

The number of embryos transferred, for each participant, by category of number of "good quality" embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=178 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 With 1 good quality embryo transferred	49 participants 3.1
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 With 2 good quality embryos transferred	65 participants 2.1
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 With 0 good quality embryos transferred	31 participants 4.5
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 With 3 good quality embryos transferred	33 participants 2.3

SECONDARY outcome

Timeframe: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

Population: Participants who received corifollitropin alfa in Treatment Cycle 1

The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 Total frozen	1.6 number of embryos Standard Deviation 2.7
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 Good quality (Grade 1 + 2)	1.2 number of embryos Standard Deviation 2.3
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 Grade 1	0.4 number of embryos Standard Deviation 1.2
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 Grade 2	0.8 number of embryos Standard Deviation 1.7
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 Grade 3	0.4 number of embryos Standard Deviation 1.0
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 Other grade	0.1 number of embryos Standard Deviation 0.4

SECONDARY outcome

Timeframe: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

Population: Participants who received corifollitropin alfa in Treatment Cycle 2

The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=375 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 Total frozen	1.1 number of embryos Standard Deviation 2.1
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 Good quality (Grade 1 + 2)	0.8 number of embryos Standard Deviation 1.7
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 Grade 1	0.3 number of embryos Standard Deviation 1.0
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 Grade 2	0.5 number of embryos Standard Deviation 1.3
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 Grade 3	0.3 number of embryos Standard Deviation 0.9
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 Other grade	0.0 number of embryos Standard Deviation 0.4

SECONDARY outcome

Timeframe: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

Population: Participants who received corifollitropin alfa in Treatment Cycle 3

The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=198 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 Total frozen	1.1 number of embryos Standard Deviation 2.2
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 Good quality (Grade 1 + 2)	0.8 number of embryos Standard Deviation 1.7
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 Grade 1	0.3 number of embryos Standard Deviation 1.1
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 Grade 2	0.5 number of embryos Standard Deviation 1.3
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 Grade 3	0.3 number of embryos Standard Deviation 1.0
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 Other grade	0.0 number of embryos Standard Deviation 0.4

SECONDARY outcome

Timeframe: Approximately 5-6 weeks after ET, within a treatment cycle

Population: Participants who received corifollitropin alfa and had ET

The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=642 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Implantation Rate for Participants With ET Cycle 1 (n=616)	21.2 percentage of embryos Standard Deviation 36.2
Implantation Rate for Participants With ET Cycle 2 (n=340)	16.6 percentage of embryos Standard Deviation 31.0
Implantation Rate for Participants With ET Cycle 3 (n=178)	16.3 percentage of embryos Standard Deviation 30.0

SECONDARY outcome

Timeframe: ≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle

Population: Participants who received corifollitropin alfa

Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 Biochemical pregnancy	340 participants
Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 Clinical pregnancy	303 participants
Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 Vital pregnancy	278 participants
Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 Ongoing pregnancy	272 participants

SECONDARY outcome

Timeframe: 10 weeks up to 9 months after ET, within a treatment cycle

Population: Participants who received corifollitropin alfa and had ongoing pregnancy in any of Treatment Cycles 1, 2 or 3

Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=272 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 Singleton ongoing pregnancy	226 participants
Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 Multiple ongoing pregnancy	46 participants

SECONDARY outcome

Timeframe: 5-6 weeks up to 9 months after ET, within a treatment cycle

Population: Participants who received corifollitropin alfa and had clinical pregnancy in any of Treatment Cycles 1, 2 or 3

Miscarriage: Loss of the fetus without induction or instrumentation, also known as "spontaneous abortion." Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=303 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3	37 participants

SECONDARY outcome

Timeframe: 5-6 weeks up to 9 months after ET, within a treatment cycle

Population: Participants who received corifollitropin alfa and had vital pregnancy in any of Treatment Cycles 1, 2 or 3

Miscarriage: Loss of the fetus without induction or instrumentation, also known as "spontaneous abortion." Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=278 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3	5 participants

SECONDARY outcome

Timeframe: From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle

Population: Participants who received corifollitropin alfa and had biochemical pregnancy in any of Treatment Cycles 1, 2 or 3

Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=340 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3	9 participants

SECONDARY outcome

Timeframe: 10 weeks up to 9 months after ET within an FTET cycle

Population: Participants who received corifollitropin alfa and had ET in any FTET cycle

After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=209 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Number of Participants With Ongoing Pregnancy in Any FTET Cycle	48 participants

SECONDARY outcome

Timeframe: Up to approximately 26 months after first dose of corifollitropin alfa

Population: Participants who received corifollitropin alfa

The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=682 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy	50.6 percentage of participants

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1

Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=658 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 Stimulation Day 1 (pre-dose) (n=651)	7.18 International Units (IU)/L Standard Deviation 2.34
Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 Stimulation Day 5 or 6 (n=648)	24.00 International Units (IU)/L Standard Deviation 6.36
Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 Stimulation Day 8 (n=634)	13.23 International Units (IU)/L Standard Deviation 3.40
Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 Day of (rec)hCG injection (n=643)	13.63 International Units (IU)/L Standard Deviation 3.69
Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 Day of embryo transfer (n=593)	3.21 International Units (IU)/L Standard Deviation 1.68
Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 2 weeks after embryo transfer (n=611)	4.84 International Units (IU)/L Standard Deviation 3.51

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2

Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=364 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum FSH Levels in Treatment Cycle 2 2 weeks after embryo transfer (n=333)	5.07 IU/L Standard Deviation 3.33
Serum FSH Levels in Treatment Cycle 2 Stimulation Day 1 (pre-dose) (n=357)	7.17 IU/L Standard Deviation 2.17
Serum FSH Levels in Treatment Cycle 2 Stimulation Day 5 or 6 (n=358)	24.24 IU/L Standard Deviation 5.75
Serum FSH Levels in Treatment Cycle 2 Stimulation Day 8 (n=346)	13.38 IU/L Standard Deviation 3.35
Serum FSH Levels in Treatment Cycle 2 Day of (rec)hCG injection (n=358)	13.78 IU/L Standard Deviation 3.74
Serum FSH Levels in Treatment Cycle 2 Day of embryo transfer (n=326)	3.20 IU/L Standard Deviation 1.45

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3

Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=190 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum FSH Levels in Treatment Cycle 3 Stimulation Day 1 (pre-dose) (n=185)	7.50 IU/L Standard Deviation 5.24
Serum FSH Levels in Treatment Cycle 3 Stimulation Day 5 or 6 (n=186)	24.51 IU/L Standard Deviation 5.93
Serum FSH Levels in Treatment Cycle 3 Stimulation Day 8 (n=184)	13.56 IU/L Standard Deviation 3.35
Serum FSH Levels in Treatment Cycle 3 Day of embryo transfer (n=168)	3.17 IU/L Standard Deviation 1.55
Serum FSH Levels in Treatment Cycle 3 2 weeks after embryo transfer (n=173)	5.01 IU/L Standard Deviation 3.40
Serum FSH Levels in Treatment Cycle 3 Day of (rec)hCG injection (n=183)	13.62 IU/L Standard Deviation 3.49

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1

Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=658 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 Stimulation Day 1 (pre-dose) (n=651)	5.07 IU/L Standard Deviation 1.86
Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 2 weeks after embryo transfer (n=611)	3.27 IU/L Standard Deviation 2.57
Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 Stimulation Day 5 or 6 (n=648)	4.86 IU/L Standard Deviation 5.39
Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 Stimulation Day 8 (n=634)	1.34 IU/L Standard Deviation 1.55
Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 Day of (rec)hCG injection (n=643)	1.53 IU/L Standard Deviation 1.98
Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 Day of embryo transfer (n=593)	NA IU/L Standard Deviation NA If more than 1/3 of the values per assessment day were smaller than the lower limit of quantitation (LLOQ) of the analytical method (0.6 IU/L), mean and SD are reported as missing.

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2

Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=364 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum LH Levels in Treatment Cycle 2 Stimulation Day 1 (pre-dose) (n=357)	5.13 IU/L Standard Deviation 1.86
Serum LH Levels in Treatment Cycle 2 Stimulation Day 5 or 6 (n=358)	4.78 IU/L Standard Deviation 5.18
Serum LH Levels in Treatment Cycle 2 Stimulation Day 8 (n=346)	1.35 IU/L Standard Deviation 1.77
Serum LH Levels in Treatment Cycle 2 Day of (rec)hCG injection (n=358)	1.67 IU/L Standard Deviation 2.15
Serum LH Levels in Treatment Cycle 2 Day of embryo transfer (n=326)	NA IU/L Standard Deviation NA If more than 1/3 of the values per assessment day were smaller than the LLOQ of the analytical method (0.6 IU/L), mean and SD are reported as missing.
Serum LH Levels in Treatment Cycle 2 2 weeks after embryo transfer (n=333)	3.41 IU/L Standard Deviation 2.48

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3

Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=190 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum LH Levels in Treatment Cycle 3 Stimulation Day 1 (pre-dose) (n=185)	5.05 IU/L Standard Deviation 1.97
Serum LH Levels in Treatment Cycle 3 Stimulation Day 5 or 6 (n=186)	4.84 IU/L Standard Deviation 5.39
Serum LH Levels in Treatment Cycle 3 Stimulation Day 8 (n=184)	1.36 IU/L Standard Deviation 1.50
Serum LH Levels in Treatment Cycle 3 Day of (rec)hCG injection (n=183)	1.79 IU/L Standard Deviation 2.71
Serum LH Levels in Treatment Cycle 3 Day of embryo transfer (n=168)	NA IU/L Standard Deviation NA If more than 1/3 of the values per assessment day were smaller than the LLOQ of the analytical method (0.6 IU/L), mean and SD are reported as missing.
Serum LH Levels in Treatment Cycle 3 2 weeks after embryo transfer (n=173)	3.57 IU/L Standard Deviation 3.13

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1

Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=658 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Estradiol Levels in Treatment Cycle 1 Stimulation Day 1 (pre-dose) (n=651)	126.07 pmol/L Standard Deviation 74.36
Serum Estradiol Levels in Treatment Cycle 1 Stimulation Day 5 or 6 (n=648)	2246.72 pmol/L Standard Deviation 1479.01
Serum Estradiol Levels in Treatment Cycle 1 Stimulation Day 8 (n=633)	3224.72 pmol/L Standard Deviation 2013.62
Serum Estradiol Levels in Treatment Cycle 1 Day of (rec)hCG injection (n=642)	5602.90 pmol/L Standard Deviation 3400.47
Serum Estradiol Levels in Treatment Cycle 1 Day of embryo transfer (n=593)	2972.22 pmol/L Standard Deviation 1758.83
Serum Estradiol Levels in Treatment Cycle 1 2 weeks after embryo transfer (n=611)	1064.92 pmol/L Standard Deviation 2006.31

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2

Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=364 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Estradiol Levels in Treatment Cycle 2 Stimulation Day 1 (pre-dose) (n=357)	120.80 pmol/L Standard Deviation 43.73
Serum Estradiol Levels in Treatment Cycle 2 Stimulation Day 5 or 6 (n=357)	2116.13 pmol/L Standard Deviation 1362.31
Serum Estradiol Levels in Treatment Cycle 2 Stimulation Day 8 (n=346)	3197.12 pmol/L Standard Deviation 2098.53
Serum Estradiol Levels in Treatment Cycle 2 Day of (rec)hCG injection (n=358)	5444.89 pmol/L Standard Deviation 2992.37
Serum Estradiol Levels in Treatment Cycle 2 Day of embryo transfer (n=324)	2988.11 pmol/L Standard Deviation 1823.81
Serum Estradiol Levels in Treatment Cycle 2 2 weeks after embryo transfer (n=333)	929.24 pmol/L Standard Deviation 1861.04

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3

Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=190 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Estradiol Levels in Treatment Cycle 3 Stimulation Day 1 (pre-dose) (n=185)	117.5 pmol/L Standard Deviation 42.10
Serum Estradiol Levels in Treatment Cycle 3 Stimulation Day 5 or 6 (n=185)	1993.66 pmol/L Standard Deviation 1372.67
Serum Estradiol Levels in Treatment Cycle 3 Stimulation Day 8 (n=184)	3164.08 pmol/L Standard Deviation 2214.33
Serum Estradiol Levels in Treatment Cycle 3 Day of (rec)hCG injection (n=183)	5605.89 pmol/L Standard Deviation 3687.99
Serum Estradiol Levels in Treatment Cycle 3 Day of embryo transfer (n=168)	3065.47 pmol/L Standard Deviation 1988.36
Serum Estradiol Levels in Treatment Cycle 3 2 weeks after embryo transfer (n=172)	746.52 pmol/L Standard Deviation 1249.66

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1

Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=658 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Progesterone Levels in Treatment Cycle 1 Stimulation Day 1 (pre-dose) (n=651)	1.99 nmol/L Standard Deviation 2.40
Serum Progesterone Levels in Treatment Cycle 1 Stimulation Day 5 or 6 (n=648)	2.72 nmol/L Standard Deviation 11.85
Serum Progesterone Levels in Treatment Cycle 1 Stimulation Day 8 (n=633)	1.85 nmol/L Standard Deviation 2.00
Serum Progesterone Levels in Treatment Cycle 1 Day of (rec)hCG injection (n=643)	4.14 nmol/L Standard Deviation 23.37
Serum Progesterone Levels in Treatment Cycle 1 Day of embryo transfer (n=593)	331.16 nmol/L Standard Deviation 169.05
Serum Progesterone Levels in Treatment Cycle 1 2 weeks after embryo transfer (n=611)	100.31 nmol/L Standard Deviation 168.53

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2

Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=364 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Progesterone Levels in Treatment Cycle 2 Day of embryo transfer (n=325)	316.28 nmol/L Standard Deviation 174.25
Serum Progesterone Levels in Treatment Cycle 2 2 weeks after embryo transfer (n=333)	88.21 nmol/L Standard Deviation 165.39
Serum Progesterone Levels in Treatment Cycle 2 Stimulation Day 1 (pre-dose) (n=357)	1.84 nmol/L Standard Deviation 1.64
Serum Progesterone Levels in Treatment Cycle 2 Stimulation Day 5 or 6 (n=358)	2.14 nmol/L Standard Deviation 1.13
Serum Progesterone Levels in Treatment Cycle 2 Stimulation Day 8 (n=346)	1.75 nmol/L Standard Deviation 1.09
Serum Progesterone Levels in Treatment Cycle 2 Day of (rec)hCG injection (n=358)	3.91 nmol/L Standard Deviation 9.14

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3

Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=190 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Progesterone Levels in Treatment Cycle 3 Stimulation Day 1 (pre-dose) (n=185)	1.76 nmol/L Standard Deviation 0.74
Serum Progesterone Levels in Treatment Cycle 3 Stimulation Day 5 or 6 (n=186)	2.29 nmol/L Standard Deviation 3.37
Serum Progesterone Levels in Treatment Cycle 3 Stimulation Day 8 (n=184)	1.75 nmol/L Standard Deviation 0.74
Serum Progesterone Levels in Treatment Cycle 3 Day of (rec)hCG injection (n=183)	4.92 nmol/L Standard Deviation 14.81
Serum Progesterone Levels in Treatment Cycle 3 Day of embryo transfer (n=168)	311.64 nmol/L Standard Deviation 161.71
Serum Progesterone Levels in Treatment Cycle 3 2 weeks after embryo transfer (n=173)	79.03 nmol/L Standard Deviation 136.60

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1

Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=658 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Inhibin-B Levels in Treatment Cycle 1 Stimulation Day 1 (pre-dose) (n=652)	48.22 pg/mL Standard Deviation 29.91
Serum Inhibin-B Levels in Treatment Cycle 1 Stimulation Day 5 or 6 (n=648)	409.63 pg/mL Standard Deviation 299.19
Serum Inhibin-B Levels in Treatment Cycle 1 Stimulation Day 8 (n=634)	455.46 pg/mL Standard Deviation 372.09
Serum Inhibin-B Levels in Treatment Cycle 1 Day of (rec)hCG injection (n=643)	523.07 pg/mL Standard Deviation 464.36
Serum Inhibin-B Levels in Treatment Cycle 1 Day of embryo transfer (n=591)	NA pg/mL Standard Deviation NA If more than 1/3 of the values per assessment day were smaller than the LLOQ of the analytical method (10 pg/mL), mean and SD are reported as missing.
Serum Inhibin-B Levels in Treatment Cycle 1 2 weeks after embryo transfer (n=611)	NA pg/mL Standard Deviation NA If more than 1/3 of the values per assessment day were smaller than the LLOQ of the analytical method (10 pg/mL), mean and SD are reported as missing.

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2

Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=364 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Inhibin-B Levels in Treatment Cycle 2 Stimulation Day 1 (pre-dose) (n=356)	48.88 pg/mL Standard Deviation 26.79
Serum Inhibin-B Levels in Treatment Cycle 2 Stimulation Day 5 or 6 (n=358)	406.29 pg/mL Standard Deviation 326.64
Serum Inhibin-B Levels in Treatment Cycle 2 Stimulation Day 8 (n=346)	443.32 pg/mL Standard Deviation 402.67
Serum Inhibin-B Levels in Treatment Cycle 2 Day of (rec)hCG injection (n=358)	505.02 pg/mL Standard Deviation 432.96
Serum Inhibin-B Levels in Treatment Cycle 2 Day of embryo transfer (n=325)	29.38 pg/mL Standard Deviation 34.99
Serum Inhibin-B Levels in Treatment Cycle 2 2 weeks after embryo transfer (n=333)	39.04 pg/mL Standard Deviation 33.74

SECONDARY outcome

Timeframe: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3

Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 µg n=190 Participants Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Serum Inhibin-B Levels in Treatment Cycle 3 Stimulation Day 1 (pre-dose) (n=185)	50.49 pg/mL Standard Deviation 28.25
Serum Inhibin-B Levels in Treatment Cycle 3 Stimulation Day 5 or 6 (n=186)	406.14 pg/mL Standard Deviation 331.91
Serum Inhibin-B Levels in Treatment Cycle 3 Stimulation Day 8 (n=184)	439.83 pg/mL Standard Deviation 374.99
Serum Inhibin-B Levels in Treatment Cycle 3 Day of (rec)hCG injection (n=183)	504.03 pg/mL Standard Deviation 437.68
Serum Inhibin-B Levels in Treatment Cycle 3 Day of embryo transfer (n=168)	26.28 pg/mL Standard Deviation 25.03
Serum Inhibin-B Levels in Treatment Cycle 3 2 weeks after embryo transfer (n=173)	40.16 pg/mL Standard Deviation 34.05

Adverse Events

Corifollitropin Alfa 150 µg

Serious events: 51 serious events

Other events: 239 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Corifollitropin Alfa 150 µg n=682 participants at risk Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Congenital, familial and genetic disorders Autosomal chromosome anomaly	0.15% 1/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Congenital, familial and genetic disorders Congenital arterial malformation	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Congenital, familial and genetic disorders Congenital uterine anomaly	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Congenital, familial and genetic disorders Cytogenetic abnormality	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Congenital, familial and genetic disorders Ectopia cordis	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Congenital, familial and genetic disorders Encephalocele	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Congenital, familial and genetic disorders Trisomy 15	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Eye disorders Conjunctivitis	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Gastrointestinal disorders Abdominal pain	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Gastrointestinal disorders Peritoneal haemorrhage	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Hepatobiliary disorders Cholelithiasis	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Infections and infestations Appendicitis	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Infections and infestations Post procedural infection	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Infections and infestations Pyelonephritis	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Infections and infestations Respiratory tract infection viral	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Injury, poisoning and procedural complications Head injury	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Musculoskeletal and connective tissue disorders Growth retardation	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Teratoma	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.29% 2/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.44% 3/682 • Number of events 3 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.29% 2/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Arrested labour	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Breech presentation	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	1.2% 8/682 • Number of events 8 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Heterotopic pregnancy	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.29% 2/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Imminent abortion	0.29% 2/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Placenta praevia haemorrhage	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Premature baby	0.44% 3/682 • Number of events 5 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Premature labour	0.29% 2/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.29% 2/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Retroplacental haematoma	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.29% 2/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Twin pregnancy	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Psychiatric disorders Psychosomatic disease	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Reproductive system and breast disorders Endometriosis	0.29% 2/682 • Number of events 2 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Reproductive system and breast disorders Fallopian tube disorder	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Reproductive system and breast disorders Ovarian haematoma	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	1.5% 10/682 • Number of events 10 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Reproductive system and breast disorders Pelvic pain	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Reproductive system and breast disorders Uterine cervix stenosis	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Surgical and medical procedures Gastric stapling reversal	0.15% 1/682 • Number of events 1 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.

Other adverse events

Other adverse events
Measure	Corifollitropin Alfa 150 µg n=682 participants at risk Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Injury, poisoning and procedural complications Procedural pain	17.7% 121/682 • Number of events 163 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Nervous system disorders Headache	9.1% 62/682 • Number of events 91 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	7.0% 48/682 • Number of events 51 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Reproductive system and breast disorders Pelvic discomfort	5.1% 35/682 • Number of events 39 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Reproductive system and breast disorders Pelvic pain	7.5% 51/682 • Number of events 60 • Up to approximately 26 months after first dose of corifollitropin alfa SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications must be based on data validated and released by the Sponsor. Any scientific paper, presentation, or other communication concerning the study must first be submitted to the Sponsor, at least 6 weeks prior to estimated publication or presentation, for written consent. Sponsor has the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the Investigator in the discussion of the data in such communications.
Publication restrictions are in place

Restriction type: OTHER