Metformin in Pregnant PCOS Women

Summary

To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.

Timeline

Start

2005-02

Primary completion

2009-10

Completion

2009-10

Outcome

Missed primary endpoint

paper The composite primary endpoint prevalence was 25.9 and 24.4%, respectively (1.5%; 95% CI, -8.9-11.3) (P=0.78). PMID 20926533 ↗

Publications

• Background Underdal MO, Stridsklev S, Oppen IH, Hogetveit K, Andersen MS, Vanky E. Does Metformin Treatment During Pregnancy Modify the Future Metabolic Profile in Women With PCOS? J Clin Endocrinol Metab. 2018 Jun 1;103(6):2408-2413. doi: 10.1210/jc.2018-00485.
• Results Vanky E, Stridsklev S, Heimstad R, Romundstad P, Skogoy K, Kleggetveit O, Hjelle S, von Brandis P, Eikeland T, Flo K, Berg KF, Bunford G, Lund A, Bjerke C, Almas I, Berg AH, Danielson A, Lahmami G, Carlsen SM. Metformin versus placebo from first trimester to delivery in polycystic ovary syndrome: a randomized, controlled multicenter study. J Clin Endocrinol Metab. 2010 Dec;95(12):E448-55. doi: 10.1210/jc.2010-0853. Epub 2010 Oct 6.
• Results Vanky E, Carlsen SM. Androgens and antimullerian hormone in mothers with polycystic ovary syndrome and their newborns. Fertil Steril. 2012 Feb;97(2):509-15. doi: 10.1016/j.fertnstert.2011.11.021. Epub 2011 Dec 10.
• Results Shetelig Lovvik T, Stridsklev S, Carlsen SM, Salvesen O, Vanky E. Cervical Length and Androgens in Pregnant Women With Polycystic Ovary Syndrome: Has Metformin Any Effect? J Clin Endocrinol Metab. 2016 Jun;101(6):2325-31. doi: 10.1210/jc.2015-3498. Epub 2016 Feb 2.
• Results Hanem LGE, Stridsklev S, Juliusson PB, Salvesen O, Roelants M, Carlsen SM, Odegard R, Vanky E. Metformin Use in PCOS Pregnancies Increases the Risk of Offspring Overweight at 4 Years of Age: Follow-Up of Two RCTs. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1612-1621. doi: 10.1210/jc.2017-02419.
• Results Hanem LGE, Salvesen O, Juliusson PB, Carlsen SM, Nossum MCF, Vaage MO, Odegard R, Vanky E. Intrauterine metformin exposure and offspring cardiometabolic risk factors (PedMet study): a 5-10 year follow-up of the PregMet randomised controlled trial. Lancet Child Adolesc Health. 2019 Mar;3(3):166-174. doi: 10.1016/S2352-4642(18)30385-7. Epub 2019 Jan 29.
• Ryssdal M, Skage JE, Jarmund AH, Hanem LGE, Lovvik TS, Giskeodegard GF, Iversen AC, Vanky E. Metformin Treatment in PCOS Pregnancies Reduces Maternal Infections and Increases the Risk of Allergies and Eczema in the Offspring: Post Hoc Analyses of Two Randomised Controlled Trials and One Follow-Up Study. BJOG. 2025 Nov;132(12):1823-1832. doi: 10.1111/1471-0528.18320. Epub 2025 Aug 11.
• Ujvari D, Trouva A, Hirschberg AL, Vanky E. Maternal serum levels of prokineticin-1 related to pregnancy complications and metformin use in women with polycystic ovary syndrome: a post hoc analysis of two prospective, randomised, placebo-controlled trials. BMJ Open. 2023 Nov 21;13(11):e073619. doi: 10.1136/bmjopen-2023-073619.
• Trouva A, Alvarsson M, Calissendorff J, Asvold BO, Vanky E, Hirschberg AL. Thyroid Status During Pregnancy in Women With Polycystic Ovary Syndrome and the Effect of Metformin. Front Endocrinol (Lausanne). 2022 Feb 21;13:772801. doi: 10.3389/fendo.2022.772801. eCollection 2022.
• Stokkeland LMT, Giskeodegard GF, Ryssdal M, Jarmund AH, Steinkjer B, Madssen TS, Stafne SN, Stridsklev S, Lovvik TS, Iversen AC, Vanky E. Changes in Serum Cytokines Throughout Pregnancy in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2022 Jan 1;107(1):39-52. doi: 10.1210/clinem/dgab684.
• Andrae F, Abbott D, Stridsklev S, Schmedes AV, Odsaeter IH, Vanky E, Salvesen O. Sustained Maternal Hyperandrogenism During PCOS Pregnancy Reduced by Metformin in Non-obese Women Carrying a Male Fetus. J Clin Endocrinol Metab. 2020 Dec 1;105(12):3762-70. doi: 10.1210/clinem/dgaa605.
• Greger HK, Hanem LGE, Ostgard HF, Vanky E. Cognitive function in metformin exposed children, born to mothers with PCOS - follow-up of an RCT. BMC Pediatr. 2020 Feb 10;20(1):60. doi: 10.1186/s12887-020-1960-2.
• Underdal MO, Salvesen O, Henriksen AH, Andersen M, Vanky E. Impaired Respiratory Function in Women With PCOS Compared With Matched Controls From a Population-Based Study. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz053. doi: 10.1210/clinem/dgz053.
• Stridsklev S, Salvesen O, Salvesen KA, Carlsen SM, Vanky E. Uterine Artery Doppler in Pregnancy: Women with PCOS Compared to Healthy Controls. Int J Endocrinol. 2018 Aug 16;2018:2604064. doi: 10.1155/2018/2604064. eCollection 2018.
• Hjorth-Hansen A, Salvesen O, Engen Hanem LG, Eggebo T, Salvesen KA, Vanky E, Odegard R. Fetal Growth and Birth Anthropometrics in Metformin-Exposed Offspring Born to Mothers With PCOS. J Clin Endocrinol Metab. 2018 Feb 1;103(2):740-747. doi: 10.1210/jc.2017-01191.
• Christiansen SC, Vanky E, Klungland H, Stafne SN, Morkved S, Salvesen KA, Saether M, Carlsen SM. The effect of exercise and metformin treatment on circulating free DNA in pregnancy. Placenta. 2014 Dec;35(12):989-93. doi: 10.1016/j.placenta.2014.09.010. Epub 2014 Sep 23.
• Helseth R, Vanky E, Stridsklev S, Vogt C, Carlsen SM. Maternal and fetal insulin levels at birth in women with polycystic ovary syndrome: data from a randomized controlled study on metformin. Eur J Endocrinol. 2014 Apr 10;170(5):769-75. doi: 10.1530/EJE-13-0859. Print 2014 May.
• Carlsen SM, Martinussen MP, Vanky E. Metformin's effect on first-year weight gain: a follow-up study. Pediatrics. 2012 Nov;130(5):e1222-6. doi: 10.1542/peds.2012-0346. Epub 2012 Oct 15.

Drugs

Indications