Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787) (NCT NCT00696800)
NCT ID: NCT00696800
Last Updated: 2024-06-20
Results Overview
An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1509 participants
Primary outcome timeframe
Assessed at least 10 weeks after embryo transfer (up to 1 year)
Results posted on
2024-06-20
Participant Flow
Of 1509 randomized participants, 1506 received treatment with either Corifollitropin Alfa or recFSH (Intent-to Treat population \[ITT\]).
Participant milestones
| Measure |
150 µg Corifollitropin Alfa
Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human Chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
200 IU recFSH
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Overall Study
STARTED
|
757
|
752
|
|
Overall Study
Treated (ITT)
|
756
|
750
|
|
Overall Study
COMPLETED
|
672
|
704
|
|
Overall Study
NOT COMPLETED
|
85
|
48
|
Reasons for withdrawal
| Measure |
150 µg Corifollitropin Alfa
Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human Chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
200 IU recFSH
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
3
|
|
Overall Study
Insufficient compliance with medication
|
2
|
1
|
|
Overall Study
Insufficient ovarian response on Day 8
|
4
|
1
|
|
Overall Study
Insufficient ovarian response
|
4
|
1
|
|
Overall Study
Risk Ovarian Hyperstimulation Syndrome
|
8
|
2
|
|
Overall Study
Too high ovarian response
|
6
|
1
|
|
Overall Study
No/too few/bad quality oocytes
|
4
|
3
|
|
Overall Study
No/abnormal fertilization
|
11
|
13
|
|
Overall Study
No/too few/bad quality embryos
|
24
|
18
|
|
Overall Study
Other Reasons
|
5
|
3
|
|
Overall Study
Not treated
|
1
|
2
|
Baseline Characteristics
A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
Baseline characteristics by cohort
| Measure |
150 µg Corifollitropin Alfa
n=756 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
200 IU recFSH
n=750 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
Total
n=1506 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.5 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
31.5 Years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
31.5 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
756 Participants
n=5 Participants
|
750 Participants
n=7 Participants
|
1506 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at least 10 weeks after embryo transfer (up to 1 year)Population: Intent to Treat (ITT) population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.
An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.
Outcome measures
| Measure |
200 IU recFSH
n=750 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=756 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)
|
38.1 Percentage of participants
|
39.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 36 hours after administration of hCG (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.
Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.
Outcome measures
| Measure |
200 IU recFSH
n=750 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=756 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Mean Number of Oocytes Retrieved
|
12.6 Number of oocytes
Standard Deviation 6.8
|
13.8 Number of oocytes
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: From Day 1 to day of hCG treatment (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.
The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 1 onwards.
Outcome measures
| Measure |
200 IU recFSH
n=741 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=733 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1
|
1800 IU
Interval 400.0 to 2800.0
|
400 IU
Interval 0.0 to 2000.0
|
SECONDARY outcome
Timeframe: From Day 8 to Day of hCG treatment (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.
The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 8 onwards.
Outcome measures
| Measure |
200 IU recFSH
n=741 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=733 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8
|
400 IU
Interval 0.0 to 1400.0
|
400 IU
Interval 0.0 to 2000.0
|
SECONDARY outcome
Timeframe: Up to day of hCG treatment (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had FSH data available.
Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Outcome measures
| Measure |
200 IU recFSH
n=724 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=732 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Serum FSH Levels During Stimulation
Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724)
|
6.60 IU/L
Standard Deviation 1.86
|
6.70 IU/L
Standard Deviation 2.05
|
|
Serum FSH Levels During Stimulation
Day 5 (Cori. Alfa N=725; recFSH N=722)
|
11.61 IU/L
Standard Deviation 3.40
|
23.49 IU/L
Standard Deviation 6.22
|
|
Serum FSH Levels During Stimulation
Day 8 (Cori. Alfa N=708; recFSH N=678)
|
11.59 IU/L
Standard Deviation 2.65
|
11.76 IU/L
Standard Deviation 3.18
|
|
Serum FSH Levels During Stimulation
Day of hCG (Cori. Alfa N=698; recFSH N=708)
|
11.59 IU/L
Standard Deviation 2.80
|
12.54 IU/L
Standard Deviation 3.35
|
SECONDARY outcome
Timeframe: Up to day of hCG treatment (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had LH data available.
Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Outcome measures
| Measure |
200 IU recFSH
n=724 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=732 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Serum Luteinizing Hormone (LH) Levels During Stimulation
Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724)
|
4.67 IU/L
Standard Deviation 1.82
|
4.80 IU/L
Standard Deviation 2.02
|
|
Serum Luteinizing Hormone (LH) Levels During Stimulation
Day 5 (Cori. Alfa N=725; recFSH N=722)
|
2.23 IU/L
Standard Deviation 2.92
|
3.62 IU/L
Standard Deviation 4.60
|
|
Serum Luteinizing Hormone (LH) Levels During Stimulation
Day 8 (Cori. Alfa N=708; recFSH N=678)
|
2.05 IU/L
Standard Deviation 1.80
|
1.29 IU/L
Standard Deviation 1.80
|
|
Serum Luteinizing Hormone (LH) Levels During Stimulation
Day of hCG (Cori. Alfa N=698; recFSH N=708)
|
1.86 IU/L
Standard Deviation 1.63
|
1.38 IU/L
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Up to day of hCG treatment (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had E2 data available.
Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Outcome measures
| Measure |
200 IU recFSH
n=724 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=732 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Serum Estradiol (E2) Levels During Stimulation
Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724)
|
124.79 pmol/L
Standard Deviation 37.11
|
126.13 pmol/L
Standard Deviation 39.17
|
|
Serum Estradiol (E2) Levels During Stimulation
Day 5 (Cori. Alfa N=725; recFSH N=722)
|
1392.97 pmol/L
Standard Deviation 895.66
|
1859.39 pmol/L
Standard Deviation 1224.78
|
|
Serum Estradiol (E2) Levels During Stimulation
Day 8 (Cori. Alfa N=708; recFSH N=678)
|
3750.96 pmol/L
Standard Deviation 2600.03
|
3700.92 pmol/L
Standard Deviation 2837.41
|
|
Serum Estradiol (E2) Levels During Stimulation
Day of hCG (Cori. Alfa N=698; recFSH N=708)
|
5154.88 pmol/L
Standard Deviation 2999.48
|
5486.67 pmol/L
Standard Deviation 3461.92
|
SECONDARY outcome
Timeframe: Up to day of hCG treatment (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had P data available.
Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment
Outcome measures
| Measure |
200 IU recFSH
n=724 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=732 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Serum Progesterone (P) Levels During Stimulation
Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724)
|
1.85 nmol/mL
Standard Deviation 1.42
|
1.80 nmol/mL
Standard Deviation 1.28
|
|
Serum Progesterone (P) Levels During Stimulation
Day 5 (Cori. Alfa N=725; recFSH N=722)
|
1.61 nmol/mL
Standard Deviation 0.87
|
2.13 nmol/mL
Standard Deviation 1.97
|
|
Serum Progesterone (P) Levels During Stimulation
Day 8 (Cori. Alfa N=708; recFSH N=678)
|
2.64 nmol/mL
Standard Deviation 1.21
|
1.95 nmol/mL
Standard Deviation 1.06
|
|
Serum Progesterone (P) Levels During Stimulation
Day of hCG (Cori. Alfa N=698; recFSH N=708)
|
3.16 nmol/mL
Standard Deviation 1.47
|
3.20 nmol/mL
Standard Deviation 4.88
|
SECONDARY outcome
Timeframe: Up to day of hCG treatment (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had Inhibin-B data available.
Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment
Outcome measures
| Measure |
200 IU recFSH
n=724 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=736 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Serum Inhibin-B Levels During Stimulation
Day 1 (Pre-dose) (Cori. Alfa N=736; recFSH N=724)
|
52.95 pg/mL
Standard Deviation 27.02
|
52.78 pg/mL
Standard Deviation 29.29
|
|
Serum Inhibin-B Levels During Stimulation
Day 5 (Cori. Alfa N=731; recFSH N=724)
|
493.86 pg/mL
Standard Deviation 329.71
|
488.54 pg/mL
Standard Deviation 380.13
|
|
Serum Inhibin-B Levels During Stimulation
Day 8 (Cori. Alfa N=713; recFSH N=679)
|
642.27 pg/mL
Standard Deviation 464.05
|
578.21 pg/mL
Standard Deviation 508.40
|
|
Serum Inhibin-B Levels During Stimulation
Day of hCG (Cori. Alfa N=704; recFSH N=710)
|
612.19 pg/mL
Standard Deviation 435.26
|
608.35 pg/mL
Standard Deviation 489.52
|
SECONDARY outcome
Timeframe: On Day 1 of treatment (up to 1 year)Population: ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 1.
Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size.
Outcome measures
| Measure |
200 IU recFSH
n=714 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=714 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Number of Follicles Categorized by Size on Stimulation Day 1
>=11 mm
|
0.1 Number of follicles
Standard Deviation 0.4
|
0.1 Number of follicles
Standard Deviation 0.3
|
|
Number of Follicles Categorized by Size on Stimulation Day 1
>=15 mm
|
0.0 Number of follicles
Standard Deviation 0.2
|
0.0 Number of follicles
Standard Deviation 0.2
|
|
Number of Follicles Categorized by Size on Stimulation Day 1
>=17 mm
|
0.0 Number of follicles
Standard Deviation 0.2
|
0.0 Number of follicles
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: On Day 5 of treatment (up to 1 year)Population: ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 5.
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Outcome measures
| Measure |
200 IU recFSH
n=749 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=748 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Number of Follicles Categorized by Size on Stimulation Day 5
>=11 mm
|
4.7 Number of follicles
Standard Deviation 3.9
|
4.4 Number of follicles
Standard Deviation 3.8
|
|
Number of Follicles Categorized by Size on Stimulation Day 5
>=15 mm
|
0.4 Number of follicles
Standard Deviation 0.9
|
0.3 Number of follicles
Standard Deviation 0.7
|
|
Number of Follicles Categorized by Size on Stimulation Day 5
>=17 mm
|
0.1 Number of follicles
Standard Deviation 0.4
|
0.1 Number of follicles
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: On Day 8 of treatment (up to 1 year)Population: ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 8.
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Outcome measures
| Measure |
200 IU recFSH
n=703 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=729 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Number of Follicles Categorized by Size on Stimulation Day 8
>=11 mm
|
11.6 Number of follicles
Standard Deviation 6.0
|
12.8 Number of follicles
Standard Deviation 6.7
|
|
Number of Follicles Categorized by Size on Stimulation Day 8
>=15 mm
|
5.2 Number of follicles
Standard Deviation 4.1
|
5.0 Number of follicles
Standard Deviation 4.6
|
|
Number of Follicles Categorized by Size on Stimulation Day 8
>=17 mm
|
2.5 Number of follicles
Standard Deviation 2.8
|
2.1 Number of follicles
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Day of HCG treatment (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection and with USS data available.
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Outcome measures
| Measure |
200 IU recFSH
n=734 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=723 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Number of Follicles Categorized by Size on the Day of hCG
>=11 mm
|
13.9 Number of follicles
Standard Deviation 6.1
|
16.0 Number of follicles
Standard Deviation 7.0
|
|
Number of Follicles Categorized by Size on the Day of hCG
>=15 mm
|
8.7 Number of follicles
Standard Deviation 4.0
|
9.6 Number of follicles
Standard Deviation 4.8
|
|
Number of Follicles Categorized by Size on the Day of hCG
>=17 mm
|
5.6 Number of follicles
Standard Deviation 2.9
|
5.7 Number of follicles
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Up to 36 hours after administration of hCG (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who underwent IVF.
Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed
Outcome measures
| Measure |
200 IU recFSH
n=240 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=242 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Number of Cumulus-oocyte-complexes
|
12.8 Number of cumulus-oocyte complexes
Standard Deviation 7.0
|
13.6 Number of cumulus-oocyte complexes
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Up to 36 hours after administration of hCG (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. For participants who had ICSI; but also includes 3 participants whose oocytes were assessed, but ICSI was not performed.
The number of oocytes used for ICSI was assessed, and categorized based on their quality
Outcome measures
| Measure |
200 IU recFSH
n=417 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=413 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)
Germinal vesicles
|
1.7 Number of oocytes
Standard Deviation 2.2
|
1.4 Number of oocytes
Standard Deviation 1.9
|
|
Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)
Total
|
12.2 Number of oocytes
Standard Deviation 6.4
|
13.8 Number of oocytes
Standard Deviation 7.7
|
|
Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)
Metaphase I
|
0.9 Number of oocytes
Standard Deviation 1.3
|
1.1 Number of oocytes
Standard Deviation 1.5
|
|
Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)
Metaphase II
|
9.2 Number of oocytes
Standard Deviation 5.1
|
10.8 Number of oocytes
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Up to 18 hours after start of fertilization (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.Restricted to participants with IVF and/or ICSI.
The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI
Outcome measures
| Measure |
200 IU recFSH
n=737 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=728 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Percentage of Fertilized Oocytes (Fertilization Rate)
|
67.6 Percentage of fertilized oocytes
Standard Deviation 22.9
|
66.0 Percentage of fertilized oocytes
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: Post fertilization Day 3 (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with IVF and/or ICSI, and excludes those who had embryos transferred or cryopreserved before Day 3.
Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: \< 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality.
Outcome measures
| Measure |
200 IU recFSH
n=729 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=714 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Number of Embryos Obtained on Day 3 Categorized by Quality
Total
|
7.5 Number of embryos
Standard Deviation 4.8
|
8.4 Number of embryos
Standard Deviation 5.5
|
|
Number of Embryos Obtained on Day 3 Categorized by Quality
Good Quality
|
4.5 Number of embryos
Standard Deviation 3.9
|
4.7 Number of embryos
Standard Deviation 4.3
|
|
Number of Embryos Obtained on Day 3 Categorized by Quality
Grade 1
|
2.5 Number of embryos
Standard Deviation 3.4
|
2.6 Number of embryos
Standard Deviation 3.4
|
|
Number of Embryos Obtained on Day 3 Categorized by Quality
Grade 2
|
2.0 Number of embryos
Standard Deviation 2.3
|
2.1 Number of embryos
Standard Deviation 2.5
|
|
Number of Embryos Obtained on Day 3 Categorized by Quality
Grade 3
|
2.0 Number of embryos
Standard Deviation 2.3
|
2.4 Number of embryos
Standard Deviation 2.6
|
|
Number of Embryos Obtained on Day 3 Categorized by Quality
Other Grade
|
1.1 Number of embryos
Standard Deviation 2.1
|
1.4 Number of embryos
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Post fertilization Day 3 (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.
After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: \< 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account.
Outcome measures
| Measure |
200 IU recFSH
n=704 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=672 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Number of Embryos Transferred on Day 3
Total
|
1.7 Number of embryos
Standard Deviation 0.4
|
1.7 Number of embryos
Standard Deviation 0.4
|
|
Number of Embryos Transferred on Day 3
Good Quality
|
1.4 Number of embryos
Standard Deviation 0.7
|
1.4 Number of embryos
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Up to 6 weeks after embryo transfer (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.
The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred.
Outcome measures
| Measure |
200 IU recFSH
n=704 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=672 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Percentage of Gestational Sacs (Implantation Rate)
|
32.2 Percentage of gestational sacs
Standard Deviation 40.1
|
36.2 Percentage of gestational sacs
Standard Deviation 41.6
|
SECONDARY outcome
Timeframe: Up to day of miscarriage (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a clinical pregnancy.
The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth.
Outcome measures
| Measure |
200 IU recFSH
n=308 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=322 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy
|
6.8 Percentage of participants
|
8.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to day of miscarriage (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a vital pregnancy.
The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity.
Outcome measures
| Measure |
200 IU recFSH
n=293 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=302 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy
|
2.0 Percentage of participants
|
2.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Two weeks after embryo transfer (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.
Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.
Outcome measures
| Measure |
200 IU recFSH
n=750 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=756 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt
|
46.9 Percentage of participants
|
48.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Two weeks after embryo transfer (up to 1 year)Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.
Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.
Outcome measures
| Measure |
200 IU recFSH
n=704 Participants
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
150 µg Corifollitropin Alfa
n=672 Participants
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer
|
50.0 Percentage of participants
|
54.2 Percentage of participants
|
Adverse Events
150 µg Corifollitropin Alfa
Serious events: 35 serious events
Other events: 403 other events
Deaths: 0 deaths
200 IU recFSH
Serious events: 30 serious events
Other events: 383 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
150 µg Corifollitropin Alfa
n=755 participants at risk
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
200 IU recFSH
n=751 participants at risk
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Gastrointestinal disorders
Nausea
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Infections and infestations
Gastroenteritis
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Infections and infestations
Influenza
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.26%
2/755 • Number of events 2 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.26%
2/755 • Number of events 2 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.53%
4/751 • Number of events 4 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Surgical and medical procedures
Abortion induced
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Surgical and medical procedures
Selective abortion
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Vascular disorders
Hypotension
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.93%
7/755 • Number of events 7 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.80%
6/751 • Number of events 6 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Heterotopic pregnancy
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.27%
2/751 • Number of events 2 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.40%
3/751 • Number of events 3 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Haematosalpinx
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.27%
2/751 • Number of events 2 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/755 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.13%
1/751 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Ovarian enlargement
|
0.13%
1/755 • Number of events 1 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
0.00%
0/751 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
1.9%
14/755 • Number of events 14 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
1.2%
9/751 • Number of events 9 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
Other adverse events
| Measure |
150 µg Corifollitropin Alfa
n=755 participants at risk
Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
200 IU recFSH
n=751 participants at risk
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.2%
77/755 • Number of events 81 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
10.9%
82/751 • Number of events 100 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
General disorders
Fatigue
|
5.7%
43/755 • Number of events 47 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
4.9%
37/751 • Number of events 41 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
7.0%
53/755 • Number of events 65 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
6.9%
52/751 • Number of events 59 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
5.7%
43/755 • Number of events 47 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
5.7%
43/751 • Number of events 46 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
22.9%
173/755 • Number of events 182 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
20.9%
157/751 • Number of events 169 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Nervous system disorders
Headache
|
10.7%
81/755 • Number of events 107 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
15.4%
116/751 • Number of events 153 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage
|
9.9%
75/755 • Number of events 104 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
8.1%
61/751 • Number of events 83 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
7.0%
53/755 • Number of events 69 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
6.3%
47/751 • Number of events 55 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
11.8%
89/755 • Number of events 128 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
11.6%
87/751 • Number of events 106 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
|
Reproductive system and breast disorders
Pelvic pain
|
12.1%
91/755 • Number of events 127 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
12.3%
92/751 • Number of events 115 • Up to 10 weeks after embryo transfer (up to 1 year)
The All-Subjects-Treated (AST) group. AST is based on the treatment actually received. Two participants randomized to the 150 µg Corifollitropin Alfa treatment group were actually treated with 200 IU recFSH, whereas one participant randomized to the 200 IU recFSH treatment group was actually treated with 150 µg Corifollitropin Alfa.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All publications must be based on data validated and released by the Sponsor. Any scientific paper, presentation or other communication concerning this clinical trial will first be submitted to the Sponsor at least six weeks before publication or presentation. The Sponsor shall have the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the investigator(s) in the discussion of the data in such communications.
- Publication restrictions are in place
Restriction type: OTHER