Hum. Reprod. Advance Access originally published online on June 3, 2004
Human Reproduction 2004 19(8):1734-1740; doi:10.1093/humrep/deh347
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Metformin reduces pregnancy complications without affecting androgen levels in pregnant polycystic ovary syndrome women: results of a randomized study
1 Department of Obstetrics and Gynaecology and 2 Section of Endocrinology, Department of Medicine, St Olavs Hospital, University Hospital of Trondheim, 3 Institute of Community Medicine and General Practice and 4 Institute of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway
5 To whom correspondence should be addressed at: Department of Obstetrics and Gynaecology, St Olavs Hospital, University Hospital of Trondheim, Olav Kyrres g. 17, N-7006 Trondheim, Norway. Email: eszter.vanky{at}medisin.ntnu.no
BACKGROUND: Investigation of a possible effect of metformin on androgen levels in pregnant women with polycystic ovary syndrome (PCOS). METHODS: A prospective, randomized, double-blind, placebo-controlled pilot study was conducted. Forty pregnant women with PCOS received diet and lifestyle counselling and were randomized to either metformin 850 mg twice daily or placebo. Primary outcome measures were changes in serum levels of dehydroepiandrosterone sulphate, androstenedione, testosterone, sex hormone-binding globulin, and free testosterone index. Secondary outcome measures were pregnancy complications and outcome. Two-tailed t-tests and 
2-tests were used. RESULTS: Maternal androgen levels were unaffected by metformin treatment in pregnant women with PCOS. While none of the 18 women in the metformin group experienced a severe pregnancy or post-partum complication, seven of the 22 (32%) women experienced severe complications in the placebo group (P=0.01). CONCLUSIONS: Metformin treatment did not reduce maternal androgen levels in pregnant women with PCOS. In the metformin-treated group we observed a reduction of severe, pregnancy and post-partum complications. Metformin treatment of pregnant PCOS women may reduce complications during pregnancy and in the post-partum period.
Key words: androgens/metformin/PCOS/pregnancy outcome
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