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.

Arzneimittel: Ganirelix

Am Stimulationstag 5 wurde mit einer täglichen SC-Injektion von 0,25 mg begonnen, die bis einschließlich des hCG-Tages andauerte

Biologisch: hCG

Wenn 3 Follikel >= 17 mm durch USS beobachtet wurden, wurde eine Einzeldosis von 10.000 IE/USP hCG verabreicht; oder für Personen mit einem Risiko für ein ovarielles Überstimulationssyndrom (OHSS) eine niedrigere Dosis von 5.000 IE/USP

Biologisch: Progesteron

Am Tag der OPU wurde die Unterstützung der Lutealphase begonnen, indem mikronisiertes Progesteron von mindestens 600 mg/Tag vaginal oder mindestens 50 mg/Tag intramuskulär (IM) verabreicht wurde, was für mindestens 6 Wochen oder bis zur Menstruation fortgesetzt wurde.

Arzneimittel: 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.

Arzneimittel: 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.

Biologisch: 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.

Arzneimittel: Ganirelix

Am Stimulationstag 5 wurde mit einer täglichen SC-Injektion von 0,25 mg begonnen, die bis einschließlich des hCG-Tages andauerte

Biologisch: hCG

Wenn 3 Follikel >= 17 mm durch USS beobachtet wurden, wurde eine Einzeldosis von 10.000 IE/USP hCG verabreicht; oder für Personen mit einem Risiko für ein ovarielles Überstimulationssyndrom (OHSS) eine niedrigere Dosis von 5.000 IE/USP

Biologisch: Progesteron

Am Tag der OPU wurde die Unterstützung der Lutealphase begonnen, indem mikronisiertes Progesteron von mindestens 600 mg/Tag vaginal oder mindestens 50 mg/Tag intramuskulär (IM) verabreicht wurde, was für mindestens 6 Wochen oder bis zur Menstruation fortgesetzt wurde.

Biologisch: 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.

Biologisch: 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.

Arzneimittel: 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.