Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)



Status:Archived
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2010
End Date:October 2012

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A Phase 3, Randomized, Double-blind, Active-controlled, Non-inferiority Trial to Investigate the Efficacy and Safety of a Single Injection of SCH 900962 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily Recombinant FSH (recFSH) as a Reference in Women Aged 35 to 42 Years (Phase 3; Protocol No. P06029)


The purpose of this study is to show that a single injection of SCH 900962 is non-inferior
to daily injections of recFSH during the first week of ovarian stimulation in terms of the
number of vital pregnancies (ie, presence of at least one fetus with heart activity as
assessed by ultrasound at least 35 days after embryo transfer) in women aged 35 to 42 years
undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or
intracytoplasmic sperm injection (ICSI).



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401-444-4000
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