No more surrogate end-points in randomised trials: the PCOSMIC trial protocol for women with polycystic ovary syndrome using metformin for infertility with clomiphene.
Current data supporting the effectiveness of metformin as a fertility treatment for women with polycystic ovary syndrome have been misinterpreted. Still unproven for women with polycystic ovary syndrome is, first, whether metformin adds to the standard first-line fertility management in all women, second, whether metformin is an effective fertility treatment for overweight women, and third, the relative fertility efficacy of metformin and clomiphene citrate as a first-line treatment in women with a lower body weight. The PCOSMIC (polycystic ovary syndrome: metformin for infertility with clomiphene) trial is an ongoing New Zealand multicentre double-blind placebo-controlled parallel randomised trial assessing these questions.
Johnson
Neil Philip
NP
University of Auckland Department of Obstetrics and Gynaecology, National Women's Health, Auckland Hospital, New Zealand. n.johnson@auckland.ac.nz
D000328:Adult; D002996:Clomiphene / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage*; D006801:Humans; D007247:Infertility, Female / Q000175:diagnosis / Q000188:drug therapy*; D016015:Logistic Models; D008687:Metformin / Q000008:administration & dosage*; D008875:Middle Aged; D018579:Patient Selection; D011085:Polycystic Ovary Syndrome / Q000175:diagnosis / Q000188:drug therapy*; D011247:Pregnancy; D011256:Pregnancy Outcome; D018873:Pregnancy Rate; D012016:Reference Values; D018570:Risk Assessment; D016896:Treatment Outcome
D005300:Fertility Agents, Female; D002996:Clomiphene; D008687:Metformin