Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

150 µg Corifollitropin Alfa

Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (Org 36286) on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from 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). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.

의약품: 가니렐릭스

자극 제5일에 매일 0.25mg의 SC 주사가 시작되었고, 이것은 hCG의 날까지 계속되었습니다.

생물학적: hCG

3개의 난포 >= 17 mm가 USS에 의해 관찰되었을 때, 10,000 IU/USP hCG의 단일 용량이 투여되었습니다; 또는 난소과자극증후군(OHSS) 위험이 있는 사람의 경우 5,000 IU/USP의 저용량

생물학적: 프로게스테론

OPU 당일에 최소 600mg/일의 미세화 프로게스테론을 질내 또는 최소 50mg/일 근육내(IM) 투여하여 황체기 지원을 시작했으며, 이는 최소 6주 동안 또는 월경까지 지속되었습니다.

의약품: 150 µg Corifollitropin Alfa

On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.

의약품: Placebo for RecFSH/Follitropin beta

Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

생물학적: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)

From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

200 IU RecFSH

Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from 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 Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. 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 study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.

의약품: 가니렐릭스

자극 제5일에 매일 0.25mg의 SC 주사가 시작되었고, 이것은 hCG의 날까지 계속되었습니다.

생물학적: hCG

3개의 난포 >= 17 mm가 USS에 의해 관찰되었을 때, 10,000 IU/USP hCG의 단일 용량이 투여되었습니다; 또는 난소과자극증후군(OHSS) 위험이 있는 사람의 경우 5,000 IU/USP의 저용량

생물학적: 프로게스테론

OPU 당일에 최소 600mg/일의 미세화 프로게스테론을 질내 또는 최소 50mg/일 근육내(IM) 투여하여 황체기 지원을 시작했으며, 이는 최소 6주 동안 또는 월경까지 지속되었습니다.

생물학적: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)

From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

생물학적: 200 IU RecFSH/Follitropin beta (Days 1 to 7)

Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

의약품: Placebo for Corifollitropin Alfa

Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.

Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)

An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.

Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy

Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.

Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy

Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.

Percentage of Participants in Follow up Trial With an Ectopic Pregnancy

An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.

Percentage of Participants in Follow up Trial With a Clinical Pregnancy

A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.

Percentage of Participants in Follow up Trial With a Vital Pregnancy

A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.

Percentage of Participants in Follow up Trial With an Ongoing Pregnancy

An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.