No more surrogate end-points in randomised trials: the PCOSMIC trial protocol for women with polycystic ovary syndrome using metformin for infertility with clomiphene

The Australian & New Zealand Journal of Obstetrics & Gynaecology
Neil Philip Johnson

Abstract

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.

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Citations

Feb 9, 2007·The New England Journal of Medicine·Richard S LegroUNKNOWN Cooperative Multicenter Reproductive Medicine Network
May 4, 2010·Human Reproduction·N P JohnsonUNKNOWN REACT-NZ (REproduction And Collaborative Trials in New Zealand), a multi-centre fertility trials group
Jun 24, 2006·BMJ : British Medical Journal·Hesham Al-Inany, Neil Johnson
Nov 15, 2007·The Journal of Clinical Endocrinology and Metabolism·Richard S LegroUNKNOWN Reproductive Medicine Network
Jan 9, 2010·Fertility and Sterility·Jane F ClarkePeter Herbison
Sep 17, 2014·Fertility and Sterility·UNKNOWN Harbin Consensus Conference Workshop Group
Jul 13, 2007·Current Opinion in Obstetrics & Gynecology

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