Today, MSD announced findings from a follow-up study to the pivotal Engage Phase III trial. Treatment with a single corifollitropin alfa injection had comparable live birth rates with daily recombinant follicle stimulating hormone (rFSH) injections for the first week of stimulation. All patients were treated with a GnRH antagonist.
These latest efficacy findings are from a follow-up study of the largest double-blind fertility agent trial performed in in-vitro fertilization (IVF) to date. In the follow-up study, patients with ongoing pregnancies were followed up to delivery. In a combined analysis of safety data from the Engage and Ensure trials (the Care program), there were no differences in neonatal outcome or congenital malformation rates between weekly corifollitropin alfa injection and daily rFSH injections.
These new data were presented today at the 2010 European Society of Human Reproduction and Embryology (ESHRE) annual meeting in Rome, Italy.
Corifollitropin alfa injection, the first and only sustained follicle stimulant, is approved in Europe for controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose may replace the first seven injections of any conventional daily rFSH preparation in a COS treatment cycle.
“This data is important for women who choose assisted reproductive technologies such as in vitro fertilization (IVF), but are concerned about the number of daily injections required during a treatment cycle,” said Robert Boostanfar, study author, reproductive endocrinologist at HRC Fertility and clinical assistant professor at the Keck School of Medicine.