title: A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer.
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.
  
  
  METHODS
  Randomized, open-label, assessor-blind, parallel groups, multicenter, noninferiority trial.
  
  
  METHODS
  Twenty-five infertility centers in seven countries.
  
  
  METHODS
  Seven hundred forty-nine women.
  
  
  METHODS
  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.
  
  
  METHODS
  Ongoing pregnancy (primary end point) and live birth rates, as well as pharmacodynamic parameters.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Highly purified hMG is at least as effective as rFSH in GnRH antagonist cycles with compulsory single-blastocyst transfer.
  
  
  BACKGROUND
  NCT00884221.
authors.affiliation: Center for Reproductive Medicine, University Hospital Brussels, Brussels, Belgium.
authors.forename: Paul
authors.initials: P
authors.lastname: Devroey
authors.forename: Antonio
authors.initials: A
authors.lastname: Pellicer
authors.forename: Anders
authors.initials: A
authors.lastname: Nyboe Andersen
authors.forename: Joan-Carles
authors.initials: JC
authors.lastname: Arce
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D001723:Birth Rate; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D037201:Follicle Stimulating Hormone, beta Subunit / Q000008:administration & dosage* / Q000009:adverse effects; D007987:Gonadotropin-Releasing Hormone / Q000037:antagonists & inhibitors* / Q000378:metabolism; D006727:Hormone Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007246:Infertility / Q000097:blood / Q000628:therapy*; D008596:Menotropins / Q000008:administration & dosage* / Q000009:adverse effects; D054315:Oocyte Retrieval; D010062:Ovulation Induction / Q000009:adverse effects / Q000379:methods*; D011247:Pregnancy; D018873:Pregnancy Rate; D011374:Progesterone / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage; D056826:Single Embryo Transfer; D013997:Time Factors; D016896:Treatment Outcome; D014421:Turkey
chemical_list: D015415:Biomarkers; D005300:Fertility Agents, Female; D037201:Follicle Stimulating Hormone, beta Subunit; D006727:Hormone Antagonists; D011994:Recombinant Proteins; D007987:Gonadotropin-Releasing Hormone; D011374:Progesterone; D008596:Menotropins