title: PCOSMIC: a multi-centre randomized trial in women with PolyCystic Ovary Syndrome evaluating Metformin for Infertility with Clomiphene.
abstract: BACKGROUND
  Ovulation induction treatment with metformin, either alone or in combination with clomiphene citrate (CC), remains controversial even though previous randomized trials have examined this.
  
  
  METHODS
  A double blinded multi-centre randomized trial was undertaken including 171 women with anovulatory or oligo-ovulatory polycystic ovary syndrome. Women with high body mass index (BMI) > 32 kg/m(2) received placebo ('standard care') or metformin; women with BMI < or = 32 kg/m(2) received CC ('standard care'), metformin or both. Treatment continued for 6 months or until pregnancy was confirmed. Primary outcomes were clinical pregnancy and live birth.
  
  
  RESULTS
  For women with BMI > 32 kg/m(2), clinical pregnancy and live birth rates were 22% (7/32) and 16% (5/32) with metformin, 15% (5/33) and 6% (2/33) with placebo. For women with BMI < or = 32 kg/m(2), clinical pregnancy and live birth rates were 40% (14/35) and 29% (10/35) with metformin, 39% (14/36) and 36% (13/36) with CC, 54% (19/35) and 43% (15/35) with combination metformin plus CC.
  
  
  CONCLUSIONS
  There is no evidence that adding metformin to 'standard care' is beneficial. Pregnancy and live birth rates are low in women with BMI > 32 kg/m(2) whatever treatment is used, with no evidence of benefit of metformin over placebo. For women with BMI < or = 32 kg/m(2) there is no evidence of significant differences in outcomes whether treated with metformin, CC or both. ClinicalTrials.gov number NCT00795808; trial protocol accepted for publication November 2005: Johnson, Aust N Z Journal Obstet Gynaecol 2006;46:141-145.
authors.affiliation: Department of Obstetrics & Gynaecology, University of Auckland, Level 12, Auckland Hospital, Auckland, New Zealand. n.johnson@auckland.ac.nz
authors.forename: N P
authors.initials: NP
authors.lastname: Johnson
authors.forename: A W
authors.initials: AW
authors.lastname: Stewart
authors.forename: J
authors.initials: J
authors.lastname: Falkiner
authors.forename: C M
authors.initials: CM
authors.lastname: Farquhar
authors.forename: S
authors.initials: S
authors.lastname: Milsom
authors.forename: V-P
authors.initials: VP
authors.lastname: Singh
authors.forename: Q L
authors.initials: QL
authors.lastname: Okonkwo
authors.forename: K L
authors.initials: KL
authors.lastname: Buckingham
mesh_terms: D000858:Anovulation / Q000188:drug therapy* / Q000209:etiology; D002996:Clomiphene / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007247:Infertility, Female / Q000188:drug therapy* / Q000209:etiology; D008687:Metformin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D010062:Ovulation Induction; D011085:Polycystic Ovary Syndrome / Q000150:complications*; D011247:Pregnancy; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D002996:Clomiphene; D008687:Metformin