To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the cumulative pregnancy rate for each treatment group.
This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment group.
Study Type
OBSERVATIONAL
Enrollment
344
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.
Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
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'.
Time frame: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
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.
Time frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
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.
Time frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
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.
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Trial With a Clinical Pregnancy
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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.
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
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.
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
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.
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
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.
Time frame: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)