PCOSMIC: a multi-centre randomized trial in women with PolyCystic Ovary Syndrome evaluating Metformin for Infertility with Clomiphene.

Autor: Johnson, N. P., Stewart, A. W., Falkiner, J., Farquhar, C. M., Milsom, S., Singh, V.-P., Okonkwo, Q. L., Buckingham, K. L.
Předmět:
Zdroj: Human Reproduction; Jul2010, Vol. 25 Issue 7, p1675-1683, 9p, 1 Diagram, 3 Charts
Abstrakt: 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;46:141-145. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index