title: Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials.
abstract: OBJECTIVE
  To summarize efficacy and safety data on a new progesterone compound which is available for subcutaneous administration as compared to vaginally administered progesterone for luteal phase support in patients undergoing IVF treatment.
  
  
  METHODS
  Data from two randomized phase III trials (07EU/Prg06 and 07USA/Prg05) performed according to GCP standards with a total sample size of 1435 per-protocol patients were meta-analyzed on an individual patient data level.
  
  
  METHODS
  University affiliated reproductive medicine unit.
  
  
  METHODS
  Subcutaneous progesterone was administered to a total of 714 subjects and vaginal progesterone was administered to a total of 721 subjects who underwent fresh embryo transfer after ovarian stimulation followed by IVF or ICSI. The subjects were between 18 and 42 years old and had a BMI <30 kg/m2.
  
  
  METHODS
  Subcutaneous progesterone 25 mg daily vs. either progesterone vaginal gel 90 mg daily (07EU/Prg06) or 100 mg intravaginal twice a day (07USA/Prg05) for luteal phase support in IVF patients.
  
  
  METHODS
  Ongoing pregnancy rate beyond 10 gestational weeks, live birth rate and OHSS risk.
  
  
  RESULTS
  The administration of subcutaneous progesterone versus intra-vaginal progesterone had no impact on ongoing pregnancy likelihood (OR = 0.865, 95% CI 0.694 to 1.077; P = n.s.), live birth likelihood (OR = 0.889, 95% CI 0.714 to 1.106; P = n.s.) or OHSS risk (OR = 0.995, 95% CI 0.565 to 1.754; P = n.s.) in regression analyses accounting for clustering of patients within trials, while adjusting for important confounders. Only female age and number of oocytes retrieved were significant predictors of live birth likelihood and OHSS risk.
  
  
  CONCLUSIONS
  No statistical significant or clinical significant differences exist between subcutaneous and vaginal progesterone for luteal phase support.
authors.affiliation: Department of Obstetrics and Gynecology, Paracelsus Medical University, Salzburg, Austria.
authors.forename: Jakob
authors.initials: J
authors.lastname: Doblinger
authors.affiliation: IBSA Institut Biochimique SA, R&D Scientific Affairs, Lugano, Switzerland.
authors.forename: Barbara
authors.initials: B
authors.lastname: Cometti
authors.affiliation: IBSA Institut Biochimique SA, R&D Scientific Affairs, Lugano, Switzerland.
authors.forename: Silvia
authors.initials: S
authors.lastname: Trevisan
authors.affiliation: Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Campus Luebeck, Luebeck, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Griesinger
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D001723:Birth Rate; D017326:Clinical Trials, Phase III as Topic; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D006801:Humans; D050498:Live Birth; D008183:Luteal Phase / Q000187:drug effects* / Q000502:physiology; D016471:Ovarian Hyperstimulation Syndrome / Q000453:epidemiology / Q000209:etiology; D010062:Ovulation Induction / Q000379:methods; D011247:Pregnancy; D018873:Pregnancy Rate; D011374:Progesterone / Q000008:administration & dosage* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011374:Progesterone