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

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


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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biomarkers / blood
  • Birth Rate
  • Drug Therapy, Combination
  • Europe
  • Female
  • Fertility Agents, Female / administration & dosage*
  • Fertility Agents, Female / adverse effects
  • Follicle Stimulating Hormone, beta Subunit / administration & dosage*
  • Follicle Stimulating Hormone, beta Subunit / adverse effects
  • Gonadotropin-Releasing Hormone / antagonists & inhibitors*
  • Gonadotropin-Releasing Hormone / metabolism
  • Hormone Antagonists / administration & dosage*
  • Hormone Antagonists / adverse effects
  • Humans
  • Infertility / blood
  • Infertility / therapy*
  • Menotropins / administration & dosage*
  • Menotropins / adverse effects
  • Oocyte Retrieval
  • Ovulation Induction / adverse effects
  • Ovulation Induction / methods*
  • Pregnancy
  • Pregnancy Rate
  • Progesterone / blood
  • Recombinant Proteins / administration & dosage
  • Single Embryo Transfer*
  • Time Factors
  • Treatment Outcome
  • Turkey


  • Biomarkers
  • Fertility Agents, Female
  • Follicle Stimulating Hormone, beta Subunit
  • Hormone Antagonists
  • Recombinant Proteins
  • Gonadotropin-Releasing Hormone
  • Progesterone
  • Menotropins

Associated data

  • ClinicalTrials.gov/NCT00884221