Trial Outcomes & Findings for Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART) (NCT NCT00505752)

Last Updated: 2014-02-13

Results Overview

Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

520 participants

Primary outcome timeframe

Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])

Results posted on

2014-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	AS900672-Enriched 50 Mcg Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels were approximately 150 picogram per milliliter \[pg/mL\] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 100 Microgram (Mcg) Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 150 Microgram (Mcg) Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	Follitropin Alfa 150 IU Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
Overall Study STARTED	132	128	128	132
Overall Study COMPLETED	126	119	120	126
Overall Study NOT COMPLETED	6	9	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	AS900672-Enriched 50 Mcg Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels were approximately 150 picogram per milliliter \[pg/mL\] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 100 Microgram (Mcg) Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 150 Microgram (Mcg) Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	Follitropin Alfa 150 IU Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
Overall Study Adverse Event	1	0	1	0
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Lack of ovarian response	1	3	0	0
Overall Study Ovarian hyperstimulation syndrome risk	1	1	3	1
Overall Study No oocytes retrieved	0	2	0	1
Overall Study No Fertilization	1	1	2	1
Overall Study All embryos/blastocysts discarded	0	0	1	1
Overall Study Other	1	2	1	2

Baseline Characteristics

Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AS900672-Enriched 50 Mcg n=132 Participants Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels were approximately 150 picogram per milliliter \[pg/mL\] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 100 Microgram (Mcg) n=128 Participants Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 150 Microgram (Mcg) n=128 Participants Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	Follitropin Alfa 150 IU n=132 Participants Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	Total n=520 Participants Total of all reporting groups
Age, Continuous	32.0 years n=5 Participants	32.0 years n=7 Participants	32.0 years n=5 Participants	32.0 years n=4 Participants	32.0 years n=21 Participants
Sex: Female, Male Female	132 Participants n=5 Participants	128 Participants n=7 Participants	128 Participants n=5 Participants	132 Participants n=4 Participants	520 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])

Population: Intention-to-treat (ITT) population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	AS900672-Enriched 50 Mcg n=130 Participants Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels were approximately 150 picogram per milliliter \[pg/mL\] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 100 Microgram (Mcg) n=122 Participants Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 150 Microgram (Mcg) n=124 Participants Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	Follitropin Alfa 150 IU n=131 Participants Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
Number of Fertilized Oocytes (2 Pronuclei [PN])	7.0 2PN oocytes Standard Deviation 4.7	8.7 2PN oocytes Standard Deviation 4.9	9.2 2PN oocytes Standard Deviation 6.0	6.7 2PN oocytes Standard Deviation 4.2

SECONDARY outcome

Timeframe: Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])

Population: ITT population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.

Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.

Outcome measures

Outcome measures
Measure	AS900672-Enriched 50 Mcg n=128 Participants Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels were approximately 150 picogram per milliliter \[pg/mL\] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 100 Microgram (Mcg) n=120 Participants Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 150 Microgram (Mcg) n=122 Participants Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	Follitropin Alfa 150 IU n=128 Participants Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
Percentage of Participants With Clinical Pregnancy	39.1 Percentage of participants	40.8 Percentage of participants	35.2 Percentage of participants	43.8 Percentage of participants

Adverse Events

AS900672-Enriched 50 Mcg

Serious events: 5 serious events

Other events: 90 other events

Deaths: 0 deaths

AS900672-Enriched 100 Microgram (Mcg)

Serious events: 5 serious events

Other events: 85 other events

Deaths: 0 deaths

AS900672-Enriched 150 Microgram (Mcg)

Serious events: 4 serious events

Other events: 84 other events

Deaths: 0 deaths

Follitropin Alfa 150 IU

Serious events: 6 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	AS900672-Enriched 50 Mcg n=132 participants at risk Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels were approximately 150 picogram per milliliter \[pg/mL\] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 100 Microgram (Mcg) n=128 participants at risk Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	AS900672-Enriched 150 Microgram (Mcg) n=128 participants at risk Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.	Follitropin Alfa 150 IU n=132 participants at risk Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
Injury, poisoning and procedural complications Procedural pain	26.5% 35/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	22.7% 29/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	21.1% 27/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	29.5% 39/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Nervous system disorders Headache	17.4% 23/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	17.2% 22/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	17.2% 22/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	21.2% 28/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Gastrointestinal disorders Abdominal distension	11.4% 15/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	12.5% 16/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	17.2% 22/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	16.7% 22/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Reproductive system and breast disorders Adnexa uteri pain	15.2% 20/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	10.9% 14/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	10.9% 14/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	11.4% 15/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Gastrointestinal disorders Nausea	8.3% 11/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	7.8% 10/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	9.4% 12/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	12.1% 16/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Reproductive system and breast disorders Uterine spasm	2.3% 3/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	5.5% 7/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	8.6% 11/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	3.8% 5/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Fatigue	3.8% 5/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	3.1% 4/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	3.1% 4/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	6.1% 8/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Musculoskeletal and connective tissue disorders Back pain	2.3% 3/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	6.2% 8/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	3.1% 4/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	3.0% 4/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Gastrointestinal disorders Constipation	2.3% 3/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	3.9% 5/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	5.5% 7/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	2.3% 3/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	4.5% 6/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	3.9% 5/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	7.8% 10/128 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.	4.5% 6/132 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.

Additional Information

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