title: Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization.
abstract: OBJECTIVE
  To compare corifollitropin alfa with recombinant FSH treatment in terms of the vital pregnancy rate in older patients undergoing IVF.
  
  
  METHODS
  Phase 3 randomized, double-blind, noninferiority trial.
  
  
  METHODS
  Multicenter trial.
  
  
  METHODS
  A total of 1,390 women aged 35-42 years.
  
  
  METHODS
  A single injection of 150 μg of corifollitropin alfa or daily 300 IU of recombinant FSH for the first 7 days then daily recombinant FSH until three follicles reach ≥17 mm in size. Ganirelix was started on stimulation day 5 up to and including the day of recombinant hCG administration. If available, two good quality embryos were transferred on day 3.
  
  
  METHODS
  Vital pregnancy rate (PR), number of oocytes, and live birth rate.
  
  
  RESULTS
  Vital PRs per started cycle were 23.9% in the corifollitropin alfa group and 26.9% in the recombinant FSH group, with an estimated difference (95% confidence interval) of -3.0% (-7.4 to 1.4). The mean (SD) number of recovered oocytes per started cycle was 10.7 (7.2) and 10.3 (6.8) in the corifollitropin alfa and the recombinant FSH groups, respectively, with an estimated difference of 0.5 (-0.2 to 1.2). The live birth rates per started cycle were 21.3% in the corifollitropin alfa group and 23.4% in the recombinant FSH group, with an estimated difference (95% confidence interval) -2.3% (-6.5 to 1.9). The incidence of serious adverse events was 0.4% versus 2.7% in the corifollitropin alfa and recombinant FSH groups, respectively, and of ovarian hyperstimulation syndrome (OHSS; all grades) was 1.7% in both groups.
  
  
  CONCLUSIONS
  Treatment with corifollitropin alfa was proven noninferior to daily recombinant FSH with respect to vital PRs, number of oocytes retrieved, and live birth rates, and was generally well tolerated.
  
  
  BACKGROUND
  NCT01144416.
authors.affiliation: Huntington Reproductive Center, Encino, California. Electronic address: boostanfarivf@havingbabies.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Boostanfar
authors.affiliation: The Fertility Center of Las Vegas, Las Vegas, Nevada.
authors.forename: Bruce
authors.initials: B
authors.lastname: Shapiro
authors.affiliation: Shady Grove Fertility, Rockville, Maryland.
authors.forename: Michael
authors.initials: M
authors.lastname: Levy
authors.affiliation: The Claudia Cohen and Ronald O. Perelman Center for Reproductive Medicine, Weill Cornell Medical College, New York, New York.
authors.forename: Zev
authors.initials: Z
authors.lastname: Rosenwaks
authors.affiliation: MSD BV, Oss, the Netherlands.
authors.forename: Han
authors.initials: H
authors.lastname: Witjes
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey.
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Stegmann
authors.affiliation: MSD BV, Oss, the Netherlands.
authors.forename: Jolanda
authors.initials: J
authors.lastname: Elbers
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey.
authors.forename: Keith
authors.initials: K
authors.lastname: Gordon
authors.affiliation: MSD BV, Oss, the Netherlands.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Mannaerts
mesh_terms: D000328:Adult; D000367:Age Factors; D004311:Double-Blind Method; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods / Q000639:trends*; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage*; D043373:Follicle Stimulating Hormone, Human / Q000008:administration & dosage*; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000037:antagonists & inhibitors*; D006727:Hormone Antagonists / Q000008:administration & dosage*; D006801:Humans; D010062:Ovulation Induction / Q000379:methods / Q000639:trends*; D011247:Pregnancy; D018873:Pregnancy Rate / Q000639:trends*; D011994:Recombinant Proteins / Q000008:administration & dosage
chemical_list: D043373:Follicle Stimulating Hormone, Human; D006727:Hormone Antagonists; D011994:Recombinant Proteins; C437186:follicle stimulating hormone, human, with HCG C-terminal peptide; D007987:Gonadotropin-Releasing Hormone; D005640:Follicle Stimulating Hormone; C061018:ganirelix
keywords: Corifollitropin alfa; GnRH antagonist; assisted reproductive technology; recombinant FSH; women aged 35–42 years