title: Clinical comparison of ovarian stimulation and luteal support agents in patients undergoing GnRH antagonist IVF cycles.
abstract: OBJECTIVE
  To explore the comparative efficacy, safety, and tolerability of agents used for ovarian stimulation and luteal support when applied in a population of women undergoing in vitro fertilization (IVF) using a gonadotropin-releasing hormone (GnRH) antagonist protocol.
  
  
  METHODS
  A phase 4, multicenter, randomized, open-label, exploratory clinical trial was performed at 7 assisted reproductive technology centers in the United States. Subjects included 173 women aged 18-42 years with a documented history of infertility who were undergoing IVF. Subjects were randomized to treatment with highly purified human menopausal gonadotropin (HP-hMG) or recombinant human follicle-stimulating hormone (rhFSH) for ovarian stimulation and progesterone vaginal inserts (PVIs) or intramuscular injection of progesterone in oil (PIO) for luteal support. Protocols for IVF followed the standard practices of participating centers within the parameters of the study.
  
  
  RESULTS
  Biochemical, clinical, and ongoing pregnancy rates were the main outcome measures. Ongoing pregnancy rates for individual treatment groups ranged from 44.0-46.9%. No statistically significant differences were observed in pregnancy outcomes for the comparisons of HP-hMG vs. rhFSH or PVI vs. PIO. All study medications were generally safe and well tolerated.
  
  
  CONCLUSIONS
  In this study HP-hMG and rhFSH were equally effective for ovarian stimulation during GnRH antagonist IVF cycles. Both PVI and PIO are viable options for luteal support.
authors.affiliation: The Advanced IVF Institute, Naperville, Illinois, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Miller
authors.forename: Edward
authors.initials: E
authors.lastname: Zbella
authors.forename: Bobby W
authors.initials: BW
authors.lastname: Webster
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Doody
authors.forename: Mark R
authors.initials: MR
authors.lastname: Bush
authors.forename: Michael G
authors.initials: MG
authors.lastname: Collins
mesh_terms: D000293:Adolescent; D000328:Adult; D003340:Corpus Luteum Maintenance; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D007987:Gonadotropin-Releasing Hormone / Q000037:antagonists & inhibitors*; D006801:Humans; D007247:Infertility, Female / Q000188:drug therapy*; D008596:Menotropins / Q000009:adverse effects / Q000627:therapeutic use*; D010062:Ovulation Induction; D011247:Pregnancy; D018873:Pregnancy Rate; D011374:Progesterone / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D005300:Fertility Agents, Female; D007987:Gonadotropin-Releasing Hormone; D011374:Progesterone; D008596:Menotropins; D005640:Follicle Stimulating Hormone