At a glance
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Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012
In Brief
An observational study evaluating corifollitropin alfa, recFSH (follitropin alfa), and 6 other interventions for In Vitro Fertilization. Completed, enrolled 102 participants.
Detailed Summary
Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.
Study Details
Timeline
Interventions
Single injection of 100 μg corifollitropin alfa administered under protocol P05690
Daily recFSH administered under protocol P05690
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
hCG 5,000 IU or 10,000 IU administered SC under protocol P05690
Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590