BACKGROUND<\/p>\n
Ovulation induction treatment with metformin, either alone or in combination with clomiphene citrate (CC), remains controversial even though previous randomized trials have examined this.<\/p>\n
METHODS<\/p>\n
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<\/sup> received placebo (‘standard care’) or metformin; women with BMI ≤ 32 kg\/m2<\/sup> 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.<\/p>\n RESULTS<\/p>\n For women with BMI > 32 kg\/m2<\/sup>, 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<\/sup>, 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.<\/p>\n CONCLUSIONS<\/p>\n 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<\/sup> whatever treatment is used, with no evidence of benefit of metformin over placebo. For women with BMI ≤ 32 kg\/m2<\/sup> there is no evidence of significant differences in outcomes whether treated with metformin, CC or both.<\/p>\n ClinicalTrials.gov number NCT00795808; trial protocol accepted for publication November 2005: Johnson, Aust N Z Journal Obstet Gynaecol<\/I> 2006;46<\/b>:141–145.<\/p>\n","protected":false},"excerpt":{"rendered":" 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 … Continue reading