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No more surrogate end‐points in randomised trials: The PCOSMIC trial protocol for women with polycystic ovary syndrome using metformin for infertility with clomiphene
Author(s) -
JOHNSON Neil Philip
Publication year - 2006
Publication title -
australian and new zealand journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.734
H-Index - 65
eISSN - 1479-828X
pISSN - 0004-8666
DOI - 10.1111/j.1479-828x.2006.00544.x
Subject(s) - polycystic ovary , metformin , medicine , infertility , gynecology , fertility , female infertility , overweight , placebo , randomized controlled trial , obstetrics , endocrinology , diabetes mellitus , obesity , pregnancy , insulin resistance , population , alternative medicine , biology , genetics , environmental health , pathology
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.