At a glance
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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38825 for Org 36286 (Corifollitropin Alfa)
In Brief
An observational study evaluating Corifollitropin alfa, GnRH antagonist, and 3 other interventions for Pregnancy and Neonates. Completed, enrolled 268 participants.
Detailed Summary
The objective of this trial is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring. In addition, a primary efficacy variable, live birth rate, was evaluated.
Study Details
Timeline
Interventions
Subcutaneous (SC) administration of corifollitropin alfa at a dose of 150 μg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
SC administration of a GnRH antagonist at a dose of 0.25 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
SC administration of (rec)hCG at a dose of 5,000-10,000 IU/250 µg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
SC administration of FSH at a dose not to exceed 225 IU/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Vaginal administration of progesterone at a dose of at least 600 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.