Objective: To compare the efficacy and safety of highly purified menotropin (hphMG) and recombinant FSH (rFSH) for controlled ovarian stimulation in a GnRH antagonist cycle with compulsory single-blastocyst transfer.
Design: Randomized, open-label, assessor-blind, parallel groups, multicenter, noninferiority trial.
Setting: Twenty-five infertility centers in seven countries.
Patient(s): Seven hundred forty-nine women.
Intervention(s): Controlled ovarian stimulation with hphMG or rFSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer on day 5 in one fresh or subsequent frozen blastocyst replacement in natural cycles initiated within 1 year of each patient's start of treatment.
Main outcome measure(s): Ongoing pregnancy (primary end point) and live birth rates, as well as pharmacodynamic parameters.
Result(s): The ongoing pregnancy rate after a fresh cycle was 30% with hphMG versus 27% with rFSH for the per-protocol (PP) population and 29% versus 27% for the intention-to-treat (ITT) population. Noninferiority of hphMG compared to rFSH was established. Considering frozen cycles initiated within 1 year, the cumulative live birth rate for a single stimulation cycle was 40% and 38% for women treated with hphMG and rFSH, respectively (both PP and ITT). Significant differences in pharmacodynamic end points were found between the two gonadotropin preparations.
Conclusion(s): Highly purified hMG is at least as effective as rFSH in GnRH antagonist cycles with compulsory single-blastocyst transfer.
Clinical trial registration number: NCT00884221.
Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.