Trial Outcomes & Findings for Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712) (NCT NCT00703014)

Last Updated: 2024-09-19

Results Overview

An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.

Recruitment status

COMPLETED

Target enrollment

541 participants

Primary outcome timeframe

Up to one day following delivery (up to 1 year)

Results posted on

2024-09-19

Participant Flow

Period one consists of mothers from the Base Trial P05787 (NCT00696800), randomized to treatment groups Corifollitropin Alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of mothers (N = 541) who enrolled in trial P05712. Period three consists of miscarried/stillborn fetuses and infants born in trial P05712.

Participant milestones

Participant milestones
Measure	Mothers Corifollitropin Alfa 150 µg Participants from the Base Trial P05787 (NCT00696800) who received a 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-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Fetuses/Infants Corifollitropin Alfa 150 µg Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)	Fetuses/Infants recFSH 200 IU Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Mothers Base Trial P05787 (NCT00696800) STARTED	757	752	0	0
Mothers Base Trial P05787 (NCT00696800) Treated	756	750	0	0
Mothers Base Trial P05787 (NCT00696800) Embryo Transfer	672	704	0	0
Mothers Base Trial P05787 (NCT00696800) COMPLETED	295	286	0	0
Mothers Base Trial P05787 (NCT00696800) NOT COMPLETED	462	466	0	0
Mothers Follow Up Trial P05712 STARTED	274	267	0	0
Mothers Follow Up Trial P05712 COMPLETED	241	235	0	0
Mothers Follow Up Trial P05712 NOT COMPLETED	33	32	0	0
Fetuses/Infants Follow Up Trial P05712 STARTED	0	0	352	326
Fetuses/Infants Follow Up Trial P05712 Live Born Infants	0	0	344	315
Fetuses/Infants Follow Up Trial P05712 COMPLETED	0	0	305	284
Fetuses/Infants Follow Up Trial P05712 NOT COMPLETED	0	0	47	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Mothers Corifollitropin Alfa 150 µg Participants from the Base Trial P05787 (NCT00696800) who received a 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-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Fetuses/Infants Corifollitropin Alfa 150 µg Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)	Fetuses/Infants recFSH 200 IU Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Mothers Follow Up Trial P05712 Did not complete follow up in P05712	33	32	0	0
Fetuses/Infants Follow Up Trial P05712 Did not complete follow up in P05712	0	0	47	42

Baseline Characteristics

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mothers Corifollitropin Alfa 150 µg n=274 Participants Participants from the Base Trial P05787 (NCT00696800) who received a 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU n=267 Participants Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Total n=541 Participants Total of all reporting groups
Age, Continuous	31.4 Years STANDARD_DEVIATION 3.2 • n=5 Participants	31.3 Years STANDARD_DEVIATION 3.5 • n=7 Participants	31.3 Years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	274 Participants n=5 Participants	267 Participants n=7 Participants	541 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: Up to one day following delivery (up to 1 year)

Population: Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Mothers Corifollitropin Alfa 150 µg n=274 Participants Participants from the Base Trial P05787 (NCT00696800) who received a 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU n=267 Participants Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)	222 Participants	214 Participants

PRIMARY outcome

Timeframe: Up to one day following delivery (up to 1 year)

Population: Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.

A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Mothers Corifollitropin Alfa 150 µg n=274 Participants Participants from the Base Trial P05787 (NCT00696800) who received a 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU n=267 Participants Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)	129 Participants	117 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks following delivery (up to 1 year)

Population: Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Mothers Corifollitropin Alfa 150 µg n=344 Participants Participants from the Base Trial P05787 (NCT00696800) who received a 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU n=315 Participants Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Number of Infants Born in Current Follow Up Trial Experiencing AEs	164 Participants	161 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks following delivery (up to 1 year)

Population: Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Mothers Corifollitropin Alfa 150 µg n=344 Participants Participants from the Base Trial P05787 (NCT00696800) who received a 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU n=315 Participants Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Number of Infants in Current Follow Up Trial Experiencing SAEs	106 Participants	94 Participants

PRIMARY outcome

Timeframe: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)

Population: Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.

The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.

Outcome measures

Outcome measures
Measure	Mothers Corifollitropin Alfa 150 µg n=756 Participants Participants from the Base Trial P05787 (NCT00696800) who received a 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU n=750 Participants Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.	35.6 Percentage of Participants	34.4 Percentage of Participants

PRIMARY outcome

Timeframe: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)

Population: Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.

The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.

Outcome measures

Outcome measures
Measure	Mothers Corifollitropin Alfa 150 µg n=672 Participants Participants from the Base Trial P05787 (NCT00696800) who received a 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU n=704 Participants Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.	40.0 Percentage of Participants	36.6 Percentage of Participants

Adverse Events

Mothers Corifollitropin Alfa 150 µg

Serious events: 129 serious events

Other events: 112 other events

Deaths: 0 deaths

Mothers recFSH 200 IU

Serious events: 117 serious events

Other events: 118 other events

Deaths: 0 deaths

Fetuses/Infants Corifollitropin Alfa 150 µg

Serious events: 106 serious events

Other events: 37 other events

Deaths: 0 deaths

Fetuses/Infants recFSH 200 IU

Serious events: 94 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any scientific paper, presentation, or other communication concerning the clinical trial will first be presented to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent. 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

Measure	Mothers Corifollitropin Alfa 150 µg n=274 participants at risk Participants from the Base Trial P05787 (NCT00696800) who received a 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Mothers recFSH 200 IU n=267 participants at risk Participants from the Base Trial P05787 (NCT00696800) who 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 from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) 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. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Fetuses/Infants Corifollitropin Alfa 150 µg n=352 participants at risk Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)	Fetuses/Infants recFSH 200 IU n=326 participants at risk Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Blood and lymphatic system disorders Anaemia	7.3% 20/274 • Number of events 20 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	6.4% 17/267 • Number of events 17 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Gastrointestinal disorders Constipation	5.5% 15/274 • Number of events 16 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	8.2% 22/267 • Number of events 23 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.57% 2/352 • Number of events 2 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	2.5% 8/326 • Number of events 8 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Gastrointestinal disorders Dyspepsia	9.9% 27/274 • Number of events 31 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	8.2% 22/267 • Number of events 23 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.2% 6/274 • Number of events 6 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	1.1% 3/267 • Number of events 3 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	4.5% 16/352 • Number of events 16 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	5.2% 17/326 • Number of events 17 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Gastrointestinal disorders Vomiting	7.3% 20/274 • Number of events 22 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	5.2% 14/267 • Number of events 15 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.92% 3/326 • Number of events 3 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
General disorders Fatigue	6.2% 17/274 • Number of events 19 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	5.6% 15/267 • Number of events 17 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
General disorders Oedema Peripheral	7.7% 21/274 • Number of events 26 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	4.9% 13/267 • Number of events 16 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Metabolism and nutrition disorders Gestational diabetes	3.6% 10/274 • Number of events 10 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	5.2% 14/267 • Number of events 14 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Musculoskeletal and connective tissue disorders Back pain	9.1% 25/274 • Number of events 28 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	7.5% 20/267 • Number of events 25 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Nervous system disorders Headache	8.8% 24/274 • Number of events 31 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	11.6% 31/267 • Number of events 37 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Pregnancy, puerperium and perinatal conditions Antepartum haemorrhage	6.9% 19/274 • Number of events 21 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	5.2% 14/267 • Number of events 19 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/274 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/267 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	6.2% 22/352 • Number of events 22 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	6.1% 20/326 • Number of events 20 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Pregnancy, puerperium and perinatal conditions Threatened labour	6.6% 18/274 • Number of events 18 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	5.6% 15/267 • Number of events 15 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Reproductive system and breast disorders Pelvic pain	5.1% 14/274 • Number of events 18 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	3.7% 10/267 • Number of events 16 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/326 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.
Gastrointestinal disorders Nausea	12.4% 34/274 • Number of events 38 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	10.1% 27/267 • Number of events 29 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.00% 0/352 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.	0.61% 2/326 • Number of events 2 • Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth All study treatments were considered to be administered to the mother.