title: Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation.
abstract: OBJECTIVE
  To assess the efficacy, safety, and local tolerance of ganirelix acetate for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH).
  
  
  METHODS
  Phase III, multicenter, open-label randomized trial.
  
  
  METHODS
  In vitro fertilization (IVF) centers in North America.
  
  
  METHODS
  Healthy female partners (n = 313) in subfertile couples for whom COH and IVF or intracytoplasmic sperm injection were indicated.
  
  
  METHODS
  Patients were randomized to receive one COH cycle with ganirelix or the reference treatment, a long protocol of leuprolide acetate in conjunction with follitropin-beta for injection.
  
  
  METHODS
  Number of oocytes retrieved, pregnancy rates, endocrine variables, and safety variables.
  
  
  RESULTS
  The mean number of oocytes retrieved per attempt was 11.6 in the ganirelix group and 14.1 in the leuprolide group. Fertilization rates were 62.4% and 61.9% in the ganirelix and leuprolide groups, respectively, and implantation rates were 21.1% and 26.1%. Clinical and ongoing pregnancy rates per attempt were 35.4% and 30.8% in the ganirelix group and 38.4% and 36.4% in the leuprolide acetate group. Fewer moderate and severe injection site reactions were reported with ganirelix (11.9% and 0.6%) than with leuprolide (24.4% and 1.1%).
  
  
  CONCLUSIONS
  Ganirelix is effective, safe, and well tolerated. Compared with leuprolide acetate, ganirelix therapy has a shorter duration and fewer injections but produces a similar pregnancy rate.
authors.affiliation: Genesis Fertility Center, Vancouver, British Columbia, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Fluker
authors.forename: J
authors.initials: J
authors.lastname: Grifo
authors.forename: A
authors.initials: A
authors.lastname: Leader
authors.forename: M
authors.initials: M
authors.lastname: Levy
authors.forename: D
authors.initials: D
authors.lastname: Meldrum
authors.forename: S J
authors.initials: SJ
authors.lastname: Muasher
authors.forename: J
authors.initials: J
authors.lastname: Rinehart
authors.forename: Z
authors.initials: Z
authors.lastname: Rosenwaks
authors.forename: R T
authors.initials: RT
authors.lastname: Scott
authors.forename: W
authors.initials: W
authors.lastname: Schoolcraft
authors.forename: D B
authors.initials: DB
authors.lastname: Shapiro
mesh_terms: D000328:Adult; D006063:Chorionic Gonadotropin / Q000097:blood; D004311:Double-Blind Method; D004622:Embryo, Mammalian / Q000187:drug effects; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage / Q000494:pharmacology; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology*; D006727:Hormone Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D010053:Ovary / Q000187:drug effects*; D011247:Pregnancy; D011374:Progesterone / Q000097:blood; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D013268:Stimulation, Chemical
chemical_list: D006063:Chorionic Gonadotropin; D006727:Hormone Antagonists; D011994:Recombinant Proteins; D007987:Gonadotropin-Releasing Hormone; D011374:Progesterone; D005640:Follicle Stimulating Hormone; D016729:Leuprolide; C061018:ganirelix