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Fertil Steril. 2012 Mar;97(3):561-71. doi: 10.1016/j.fertnstert.2011.12.016. Epub 2012 Jan 13.

A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer.

Author information

1
Center for Reproductive Medicine, University Hospital Brussels, Brussels, Belgium.

Abstract

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.

[Indexed for MEDLINE]

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