title: Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study.
abstract: OBJECTIVE
  To compare the safety, efficacy, and tolerability of subcutaneous progesterone (Prolutex, 25 mg; IBSA Institut Biochimique SA) with vaginal progesterone gel (Crinone, 8%; Merck Serono) for luteal phase support (LPS) in assisted reproduction technologies (ART) patients.
  
  
  METHODS
  Prospective, open-label, randomized, controlled, parallel-group, multicenter, two-arm, noninferiority study.
  
  
  METHODS
  Thirteen European fertility clinics.
  
  
  METHODS
  A total of 683 ART patients randomized to two groups: Prolutex, 25 mg subcutaneously daily (n = 339); and Crinone, 90 mg 8% gel daily (n = 344).
  
  
  METHODS
  In vitro fertilization and embryo transfer were performed according to site-specific protocols. On the day of oocyte retrieval, Prolutex or Crinone gel was begun for LPS and continued for up to 10 weeks.
  
  
  METHODS
  Ongoing pregnancy rate.
  
  
  RESULTS
  The primary end point, ongoing pregnancy rates at 10 weeks of treatment were 27.4% and 30.5% in the Prolutex and Crinone groups, respectively (intention to treat [ITT]). The nonsignificant difference between the groups was -3.09% (95% confidence interval [CI] -9.91-3.73), indicating noninferiority of Prolutex to Crinone. Delivery and live birth rates resulted to be equivalent between the two treatments (26.8% vs. 29.9% in the Prolutex and Crinone groups, respectively [ITT]; difference -3.10 [95% CI -9.87-3.68]). No statistically significant differences were reported for any of the other secondary efficacy endpoints, including comfort of usage and overall satisfaction.
  
  
  CONCLUSIONS
  Implantation rate, pregnancy rate, live birth rate, and early miscarriage rate for Prolutex were similar to those for Crinone. The adverse event profiles were similar and Prolutex was safe and well tolerated.
  
  
  BACKGROUND
  NCT00827983.
authors.affiliation: Midland Fertility Services, Aldridge, United Kingdom.
authors.forename: Gillian
authors.initials: G
authors.lastname: Lockwood
authors.affiliation: University of Lübeck, Lübeck, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Griesinger
authors.affiliation: Institut Biochimique, Lugano, Switzerland. Electronic address: barbara.cometti@ibsa.ch.
authors.forename: Barbara
authors.initials: B
authors.lastname: Cometti
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D005782:Gels; D006801:Humans; D007247:Infertility, Female / Q000453:epidemiology / Q000378:metabolism / Q000628:therapy*; D007279:Injections, Subcutaneous; D050498:Live Birth / Q000453:epidemiology; D008183:Luteal Phase / Q000187:drug effects* / Q000378:metabolism; D011247:Pregnancy; D011374:Progesterone / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005782:Gels; D011374:Progesterone
keywords: Luteal phase support; intracytoplasmic sperm injection; in vitro fertilization; pregnancy; progesterone