Trial Outcomes & Findings for To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001) (NCT NCT00702845)
NCT ID: NCT00702845
Last Updated: 2024-06-18
Results Overview
The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
397 participants
Primary outcome timeframe
One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
100 μg Corifollitropin Alfa
Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Overall Study
STARTED
|
268
|
129
|
|
Overall Study
Randomized
|
268
|
128
|
|
Overall Study
COMPLETED
|
246
|
121
|
|
Overall Study
NOT COMPLETED
|
22
|
8
|
Reasons for withdrawal
| Measure |
100 μg Corifollitropin Alfa
Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Overall Study
No/too few/bad quality oocytes retrieved
|
2
|
2
|
|
Overall Study
Too high ovarian response
|
5
|
1
|
|
Overall Study
Risk of ovarian hyperstimulation synd.
|
1
|
0
|
|
Overall Study
Insufficient ovarian response
|
1
|
0
|
|
Overall Study
No/too few/bad quality embryos retrieved
|
7
|
1
|
|
Overall Study
No or abnormal fertilization
|
4
|
2
|
|
Overall Study
Patient's decision
|
2
|
1
|
|
Overall Study
Not randomized
|
0
|
1
|
Baseline Characteristics
To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
Baseline characteristics by cohort
| Measure |
100 μg Corifollitropin Alfa
n=268 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=128 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.9 Years
STANDARD_DEVIATION 3.2 • n=93 Participants
|
31.1 Years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
31.0 Years
STANDARD_DEVIATION 3.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
268 Participants
n=93 Participants
|
128 Participants
n=4 Participants
|
396 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)Population: Intent-to-Treat (ITT) Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.
The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=268 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=128 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Number of Cumulus-oocyte-complexes Retrieved, Per Attempt
|
13.3 Number of cumulus-oocyte-complexes
Standard Deviation 7.3
|
10.6 Number of cumulus-oocyte-complexes
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: One COS cycle (up to a maximum total duration of 19 stimulation days)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles \>=17mm).
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=266 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Total Dose of recFSH Administered
|
300.0 International Unit (IU)
Interval 0.0 to 1550.0
|
1350.0 International Unit (IU)
Interval 825.0 to 2650.0
|
SECONDARY outcome
Timeframe: Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles \>=17mm).
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=266 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Total Dose of recFSH Administered From Day 8 Onwards
|
300.0 International Unit (IU)
Interval 0.0 to 1550.0
|
275.0 International Unit (IU)
Interval 0.0 to 1600.0
|
SECONDARY outcome
Timeframe: One COS cycle (up to a maximum total duration of 19 stimulation days)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles \>=17mm).
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=266 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Number of Days Treated With recFSH
|
2.0 Days
Interval 0.0 to 7.0
|
9.0 Days
Interval 6.0 to 15.0
|
SECONDARY outcome
Timeframe: One COS cycle (up to a maximum total duration of 19 stimulation days)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=266 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Total Duration of Stimulation (Days)
|
9.0 Days
Interval 6.0 to 15.0
|
9.0 Days
Interval 6.0 to 15.0
|
SECONDARY outcome
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=268 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 1 (pre-dose) (n=265,122)
|
6.46 IU/L
Full Range 1.84 • Interval 1.2 to 14.0
|
6.51 IU/L
Full Range 1.89 • Interval 1.9 to 15.4
|
|
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 3 (n=265,127)
|
26.30 IU/L
Full Range 7.14 • Interval 15.2 to 51.1
|
9.18 IU/L
Full Range 2.48 • Interval 4.7 to 22.3
|
|
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 5 (n=265,127)
|
19.50 IU/L
Full Range 4.52 • Interval 0.8 to 34.7
|
10.20 IU/L
Full Range 2.98 • Interval 1.0 to 28.0
|
|
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 8 (n=255,121)
|
10.10 IU/L
Full Range 2.12 • Interval 5.0 to 18.1
|
10.30 IU/L
Full Range 2.26 • Interval 4.5 to 23.6
|
|
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
Day of hCG injection (n=262,126)
|
11.50 IU/L
Full Range 2.65 • Interval 5.0 to 19.9
|
10.65 IU/L
Full Range 3.57 • Interval 5.9 to 41.8
|
|
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
Day of ET (n=242,121)
|
2.52 IU/L
Full Range 1.05 • Interval 0.4 to 5.8
|
1.32 IU/L
Full Range 1.02 • Interval 0.4 to 8.4
|
|
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
2 weeks after ET (n=245,121)
|
4.46 IU/L
Full Range 3.53 • Interval 0.1 to 16.6
|
1.90 IU/L
Full Range NA • Interval 0.1 to 11.5
|
SECONDARY outcome
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=266 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 1 (pre-dose) (n=265,122)
|
4.46 IU/L
Full Range 1.81 • Interval 0.3 to 13.3
|
4.12 IU/L
Full Range 1.94 • Interval 0.3 to 14.7
|
|
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 3 (n=265,127)
|
1.18 IU/L
Full Range 0.80 • Interval 0.3 to 6.3
|
1.46 IU/L
Full Range 1.00 • Interval 0.3 to 6.8
|
|
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 5 (n=264,127)
|
1.91 IU/L
Full Range 3.70 • Interval 0.3 to 33.3
|
1.49 IU/L
Full Range 7.26 • Interval 0.3 to 76.7
|
|
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 8 (n=255,121)
|
0.82 IU/L
Full Range NA • Interval 0.3 to 9.9
|
1.60 IU/L
Full Range 2.35 • Interval 0.3 to 17.8
|
|
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
Day of hCG injection (n=262,126)
|
0.88 IU/L
Full Range NA • Interval 0.3 to 9.9
|
1.30 IU/L
Full Range 2.06 • Interval 0.3 to 12.5
|
|
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
Day of ET (n=242,121)
|
NA IU/L
Full Range NA • Interval 0.3 to 4.1
If more than 1/2 of the values per assessment day were smaller than the lower limit of quantification (LLOQ) (0.6 IU/L), the median was reported as missing.
|
NA IU/L
Full Range NA • Interval 0.3 to 5.6
If more than 1/2 of the values per assessment day were smaller than LLOQ (0.6 IU/L), the median was reported as missing.
|
|
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
2 weeks after ET (n=245,121)
|
2.38 IU/L
Full Range NA • Interval 0.3 to 16.2
|
1.02 IU/L
Full Range NA • Interval 0.3 to 24.4
|
SECONDARY outcome
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=266 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
Day of ET (n=242,121)
|
3475.49 pmol/L
Full Range 2640.49 • Interval 433.1 to 16258.1
|
3670.00 pmol/L
Full Range 2946.26 • Interval 612.9 to 18460.1
|
|
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 1 (pre-dose) (n=265,122)
|
118.17 pmol/L
Full Range 53.18 • Interval 25.0 to 466.1
|
120.38 pmol/L
Full Range 71.07 • Interval 25.0 to 748.7
|
|
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 3 (n=265,127)
|
803.73 pmol/L
Full Range 553.18 • Interval 76.7 to 4917.8
|
506.46 pmol/L
Full Range 369.66 • Interval 25.0 to 2719.5
|
|
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 5 (n=265,127)
|
1901.06 pmol/L
Full Range 1490.48 • Interval 165.9 to 9578.7
|
1295.51 pmol/L
Full Range 1015.75 • Interval 25.0 to 6128.9
|
|
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 8 (n=255,121)
|
2899.30 pmol/L
Full Range 2632.83 • Interval 282.2 to 20441.9
|
3167.21 pmol/L
Full Range 2710.16 • Interval 111.2 to 14606.6
|
|
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
Day of hCG injection (n=262,126)
|
4440.70 pmol/L
Full Range 3355.95 • Interval 690.0 to 20441.9
|
4440.70 pmol/L
Full Range 3114.93 • Interval 987.2 to 16111.3
|
|
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
2 weeks after ET (n=245,121)
|
168.45 pmol/L
Full Range 3002.09 • Interval 25.0 to 17579.3
|
392.69 pmol/L
Full Range 2889.61 • Interval 25.0 to 18313.3
|
SECONDARY outcome
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=266 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 1 (pre-dose) (n=264,120)
|
1.36 nmol/L
Full Range 2.90 • Interval 0.6 to 33.4
|
1.40 nmol/L
Full Range 0.97 • Interval 0.6 to 9.3
|
|
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 3 (n=263,126)
|
1.23 nmol/L
Full Range NA • Interval 0.6 to 11.7
|
NA nmol/L
Full Range NA • Interval 0.6 to 3.3
If more than 1/2 of the values per assessment day were smaller than LLOQ (1.2 nmol/L), the median was reported as missing.
|
|
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 5 (n=265,127)
|
1.65 nmol/L
Full Range 3.27 • Interval 0.6 to 53.7
|
1.28 nmol/L
Full Range NA • Interval 0.6 to 93.8
|
|
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
Stimulation Day 8 (n=255,121)
|
1.39 nmol/L
Full Range 0.64 • Interval 0.6 to 3.3
|
2.03 nmol/L
Full Range 1.11 • Interval 0.6 to 6.2
|
|
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
Day of hCG injection (n=262,126)
|
2.10 nmol/L
Full Range 1.34 • Interval 0.6 to 8.4
|
2.39 nmol/L
Full Range 1.78 • Interval 0.6 to 15.6
|
|
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
Day of ET (n=242,121)
|
421.35 nmol/L
Full Range 223.93 • Interval 82.7 to 960.4
|
333.90 nmol/L
Full Range 157.38 • Interval 45.2 to 852.2
|
|
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
2 weeks after ET (n=244,120)
|
38.64 nmol/L
Full Range 263.88 • Interval 0.6 to 960.4
|
51.99 nmol/L
Full Range 236.91 • Interval 0.6 to 960.4
|
SECONDARY outcome
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=266 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=127 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
Stimulation Day 1 (pre-dose) (n=265,123)
|
54.20 pg/mL
Full Range 26.40 • Interval 5.0 to 178.0
|
57.80 pg/mL
Full Range 168.69 • Interval 5.0 to 1910.0
|
|
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
Stimulation Day 3 (n=265,127)
|
351.00 pg/mL
Full Range 216.79 • Interval 5.0 to 1590.0
|
259.00 pg/mL
Full Range 143.21 • Interval 5.0 to 747.0
|
|
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
Stimulation Day 5 (n=264,127)
|
598.00 pg/mL
Full Range 527.96 • Interval 17.3 to 3080.0
|
489.00 pg/mL
Full Range 348.64 • Interval 5.0 to 2470.0
|
|
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
Stimulation Day 8 (n=255,121)
|
619.00 pg/mL
Full Range 643.76 • Interval 56.0 to 4000.0
|
650.00 pg/mL
Full Range 536.39 • Interval 20.1 to 2670.0
|
|
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
Day of hCG injection (n=262,126)
|
729.50 pg/mL
Full Range 721.20 • Interval 56.0 to 4000.0
|
615.50 pg/mL
Full Range 571.49 • Interval 5.0 to 2870.0
|
|
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
Day of ET (n=242,121)
|
18.20 pg/mL
Full Range 25.49 • Interval 5.0 to 173.0
|
17.00 pg/mL
Full Range 29.36 • Interval 5.0 to 167.0
|
|
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
2 weeks after ET (n=245,121)
|
17.50 pg/mL
Full Range NA • Interval 5.0 to 613.0
|
NA pg/mL
Full Range NA • Interval 5.0 to 163.0
If more than 1/2 of the values per assessment day were smaller than LLOQ (10 pg/mL), the median was reported as missing
|
SECONDARY outcome
Timeframe: Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.
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
| Measure |
100 μg Corifollitropin Alfa
n=268 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=128 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 1, >=11mm (n=266,124)
|
0.0 Follicles
Standard Deviation 0.1
|
0.0 Follicles
Standard Deviation 0.2
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 1, >=15mm (n=266,124)
|
0.0 Follicles
Standard Deviation 0.1
|
0.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 1, >=17mm (n=266,124)
|
0.0 Follicles
Standard Deviation 0.1
|
0.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 3, >=11mm (n=268,128)
|
0.6 Follicles
Standard Deviation 1.7
|
0.5 Follicles
Standard Deviation 0.9
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 3, >=15mm (n=268,128)
|
0.0 Follicles
Standard Deviation 0.1
|
0.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 3, >=17mm (n=268,128)
|
0.0 Follicles
Standard Deviation 0.0
|
0.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 5, >=11mm (n=267,128)
|
4.7 Follicles
Standard Deviation 3.6
|
4.1 Follicles
Standard Deviation 3.2
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 5, >=15mm (n=267,128)
|
0.3 Follicles
Standard Deviation 0.7
|
0.3 Follicles
Standard Deviation 0.9
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 5, >=17mm (n=267,128)
|
0.0 Follicles
Standard Deviation 0.2
|
0.0 Follicles
Standard Deviation 0.1
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 6, >=11mm (n=9,5)
|
7.6 Follicles
Standard Deviation 5.2
|
8.6 Follicles
Standard Deviation 6.3
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 6, >=15mm (n=9,5)
|
1.8 Follicles
Standard Deviation 3.0
|
4.0 Follicles
Standard Deviation 3.8
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 6, >=17mm (n=9,5)
|
0.7 Follicles
Standard Deviation 1.3
|
1.8 Follicles
Standard Deviation 2.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 7, >=11mm (n=30,12)
|
11.9 Follicles
Standard Deviation 6.8
|
9.2 Follicles
Standard Deviation 4.4
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 7, >=15mm (n=30,12)
|
4.5 Follicles
Standard Deviation 4.7
|
3.3 Follicles
Standard Deviation 2.8
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 7, >=17mm (n=30,12)
|
1.8 Follicles
Standard Deviation 2.8
|
1.1 Follicles
Standard Deviation 1.3
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 8, >=11mm (n=259,121)
|
11.8 Follicles
Standard Deviation 6.1
|
10.6 Follicles
Standard Deviation 5.3
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 8, >=15mm (n=259,121)
|
5.0 Follicles
Standard Deviation 4.6
|
5.1 Follicles
Standard Deviation 4.5
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 8, >=17mm (n=259,121)
|
2.0 Follicles
Standard Deviation 3.0
|
2.4 Follicles
Standard Deviation 3.1
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 9, >=11mm (n=185,76)
|
13.4 Follicles
Standard Deviation 6.5
|
11.1 Follicles
Standard Deviation 5.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 9, >=15mm (n=185,76)
|
6.9 Follicles
Standard Deviation 4.7
|
6.0 Follicles
Standard Deviation 4.5
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 9, >=17mm (n=185,76)
|
2.6 Follicles
Standard Deviation 2.5
|
2.6 Follicles
Standard Deviation 2.5
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 10, >=11mm (n=101,40)
|
13.9 Follicles
Standard Deviation 6.7
|
13.0 Follicles
Standard Deviation 6.4
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 10, >=15mm (n=101,40)
|
7.4 Follicles
Standard Deviation 4.9
|
7.5 Follicles
Standard Deviation 5.3
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 10, >=17mm (n=101,40)
|
3.6 Follicles
Standard Deviation 3.5
|
4.0 Follicles
Standard Deviation 4.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 11, >=11mm (n=38,14)
|
13.9 Follicles
Standard Deviation 6.7
|
11.6 Follicles
Standard Deviation 7.1
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 11, >=15mm (n=38,14)
|
7.7 Follicles
Standard Deviation 5.7
|
7.1 Follicles
Standard Deviation 4.6
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 11, >=17mm (n=38,14)
|
3.9 Follicles
Standard Deviation 3.8
|
3.8 Follicles
Standard Deviation 3.5
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 12, >=11mm (n=17,6)
|
12.7 Follicles
Standard Deviation 5.4
|
9.3 Follicles
Standard Deviation 4.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 12, >=15mm (n=17,6)
|
6.8 Follicles
Standard Deviation 3.5
|
5.2 Follicles
Standard Deviation 2.9
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 12, >=17mm (n=17,6)
|
3.5 Follicles
Standard Deviation 2.8
|
2.7 Follicles
Standard Deviation 2.1
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 13, >=11mm (n=5,4)
|
17.0 Follicles
Standard Deviation 9.5
|
10.3 Follicles
Standard Deviation 5.4
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 13, >=15mm (n=5,4)
|
10.6 Follicles
Standard Deviation 8.6
|
6.3 Follicles
Standard Deviation 4.5
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 13, >=17mm (n=5,4)
|
4.4 Follicles
Standard Deviation 6.2
|
4.0 Follicles
Standard Deviation 3.4
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 14, >=11mm (n=2,1)
|
13.5 Follicles
Standard Deviation 12.0
|
3.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 14, >=15mm (n=2,1)
|
10.5 Follicles
Standard Deviation 12.0
|
0.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 14, >=17mm (n=2,1)
|
6.0 Follicles
Standard Deviation 5.7
|
0.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 15, >=11mm (n=1,1)
|
7.0 Follicles
Standard Deviation 0.0
|
4.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 15, >=15mm (n=1,1)
|
4.0 Follicles
Standard Deviation 0.0
|
4.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Stimulation Day 15, >=17mm (n=1,1)
|
2.0 Follicles
Standard Deviation 0.0
|
3.0 Follicles
Standard Deviation 0.0
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Day of hCG administration, >=11mm (n=266,127)
|
14.9 Follicles
Standard Deviation 6.6
|
12.9 Follicles
Standard Deviation 5.8
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Day of hCG administration, >=15mm (n=266,127)
|
9.4 Follicles
Standard Deviation 4.9
|
8.5 Follicles
Standard Deviation 4.4
|
|
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Day of hCG administration, >=17mm (n=266,127)
|
5.3 Follicles
Standard Deviation 3.0
|
5.1 Follicles
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Up to 36 hours after administration of hCGPopulation: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ICSI.
The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=137 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=72 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)
Oocytes assessed prior to ICSI
|
12.7 Number of oocytes
Standard Deviation 6.8
|
9.9 Number of oocytes
Standard Deviation 5.4
|
|
Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)
Metaphase I oocytes
|
0.8 Number of oocytes
Standard Deviation 1.2
|
0.7 Number of oocytes
Standard Deviation 1.2
|
|
Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)
Metaphase II oocytes
|
10.7 Number of oocytes
Standard Deviation 6.4
|
7.8 Number of oocytes
Standard Deviation 4.8
|
|
Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)
Germinal vesicles stage oocytes
|
1.1 Number of oocytes
Standard Deviation 1.6
|
1.3 Number of oocytes
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Up to 10 weeks after ETPopulation: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received fertilized oocytes.
Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=264 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=124 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Fertilization Rate
|
67.6 Percentage
Standard Deviation 22.5
|
67.7 Percentage
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent IVF and/or ICSI.
Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. "Other" grade embryos were those that did not qualify as Grade 1, 2, or 3.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=264 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=124 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
Grade 1
|
1.7 Number of embryos
Standard Deviation 2.3
|
1.4 Number of embryos
Standard Deviation 2.1
|
|
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
Total (n=259,123)
|
7.2 Number of embryos
Standard Deviation 4.1
|
6.2 Number of embryos
Standard Deviation 4.0
|
|
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
Good quality
|
3.4 Number of embryos
Standard Deviation 3.0
|
3.0 Number of embryos
Standard Deviation 3.0
|
|
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
Grade 2
|
1.8 Number of embryos
Standard Deviation 1.9
|
1.6 Number of embryos
Standard Deviation 1.9
|
|
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
Grade 3
|
2.8 Number of embryos
Standard Deviation 2.8
|
2.4 Number of embryos
Standard Deviation 2.4
|
|
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
Other
|
1.0 Number of embryos
Standard Deviation 1.6
|
0.7 Number of embryos
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ET.
The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=246 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=121 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Implantation Rate for Participants With ET
|
23.6 Percentage
Standard Deviation 37.4
|
28.5 Percentage
Standard Deviation 38.6
|
SECONDARY outcome
Timeframe: Up to 10 weeks after ET (up to a maximum of 14 weeks)Population: Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who had a biological pregnancy.
A miscarriage, also known as a "spontaneous abortion," was defined as the loss of a fetus without induction or instrumentation.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=268 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=128 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Number of Participants With Miscarriages
Per clinical pregnancy (n=78,48)
|
10 Participants
12.8
|
4 Participants
8.3
|
|
Number of Participants With Miscarriages
Per vital pregnancy (n=69,45)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 weeks after ET (up to a maximum of 14 weeks)Population: ITT Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.
A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.
Outcome measures
| Measure |
100 μg Corifollitropin Alfa
n=268 Participants
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=128 Participants
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Number of Participants With Pregnancies
Biochemical pregnancy, per attempt (n=268,128)
|
101 Participants
|
58 Participants
|
|
Number of Participants With Pregnancies
Biochemical pregnancy, per ET (n=246,121)
|
101 Participants
|
58 Participants
|
|
Number of Participants With Pregnancies
Clinical pregnancy, per attempt (n=268,128)
|
78 Participants
|
48 Participants
|
|
Number of Participants With Pregnancies
Clinical pregnancy, per ET (n=246,121)
|
78 Participants
|
48 Participants
|
|
Number of Participants With Pregnancies
Vital pregnancy, per attempt (n=268,128)
|
69 Participants
|
45 Participants
|
|
Number of Participants With Pregnancies
Vital pregnancy, per ET (n=246,121)
|
69 Participants
|
45 Participants
|
|
Number of Participants With Pregnancies
Ongoing pregnancy, per attempt (n=268,128)
|
68 Participants
|
44 Participants
|
|
Number of Participants With Pregnancies
Ongoing pregnancy, per ET (n=246,121)
|
68 Participants
|
44 Participants
|
Adverse Events
100 μg Corifollitropin Alfa
Serious events: 20 serious events
Other events: 107 other events
Deaths: 0 deaths
150 IU recFSH
Serious events: 9 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 μg Corifollitropin Alfa
n=268 participants at risk
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=129 participants at risk
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Heterotopic pregnancy
|
0.00%
0/268 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.78%
1/129 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/268 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.78%
1/129 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.00%
0/268 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.78%
1/129 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/268 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.78%
1/129 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
2.6%
7/268 • Number of events 7 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.00%
0/129 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.37%
1/268 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.00%
0/129 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/268 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.78%
1/129 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/268 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.78%
1/129 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Surgical and medical procedures
Selective abortion
|
0.37%
1/268 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.00%
0/129 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/268 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.78%
1/129 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.37%
1/268 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.00%
0/129 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.37%
1/268 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.00%
0/129 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.75%
2/268 • Number of events 2 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.00%
0/129 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.37%
1/268 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.00%
0/129 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage
|
0.00%
0/268 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
0.78%
1/129 • Number of events 1 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
3.0%
8/268 • Number of events 8 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
1.6%
2/129 • Number of events 2 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
Other adverse events
| Measure |
100 μg Corifollitropin Alfa
n=268 participants at risk
Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
|
150 IU recFSH
n=129 participants at risk
Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.9%
13/268 • Number of events 13 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
5.4%
7/129 • Number of events 7 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Nervous system disorders
Headache
|
9.3%
25/268 • Number of events 30 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
9.3%
12/129 • Number of events 17 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
5.2%
14/268 • Number of events 14 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
6.2%
8/129 • Number of events 8 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage
|
6.7%
18/268 • Number of events 22 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
13.2%
17/129 • Number of events 17 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
5.2%
14/268 • Number of events 15 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
4.7%
6/129 • Number of events 7 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
10.1%
27/268 • Number of events 42 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
14.7%
19/129 • Number of events 24 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
|
Reproductive system and breast disorders
Pelvic pain
|
10.8%
29/268 • Number of events 30 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
10.9%
14/129 • Number of events 17 • Up to 10 weeks after ET (up to a maximum of 14 weeks)
All Participants Treated Group, which included one treated participant who was not randomized.
|
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 Any scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
- Publication restrictions are in place
Restriction type: OTHER