Author: Johnson N.P. Stewart A.W. Falkiner J. Farquhar C.M. Milsom S. Singh V.-P. Okonkwo Q.L. Buckingham K.L.
Publisher: Oxford University Press
ISSN: 1460-2350
Source: Human Reproduction, Vol.25, Iss.7, 2010-07, pp. : 1675-1683
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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/m2 received placebo (standard care) or metformin; women with BMI 32 kg/m2 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/m2, 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 32 kg/m2, 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/m2 whatever treatment is used, with no evidence of benefit of metformin over placebo. For women with BMI 32 kg/m2 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;46:141145.
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