L26/O-018 Pre-conception and first trimester metformin on miscarriage risk in women with polycystic ovary syndrome: a randomised, placebo-controlled trial
Abstract
What is the effect of pre-conception metformin continued through the first trimester on miscarriage risk in women with polycystic ovary syndrome?
The findings from this multicentre, double-blind, randomised, placebo-controlled trial investigating metformin for miscarriage prevention in women with polycystic ovary syndrome will be presented.
Women with polycystic ovary syndrome (PCOS) have an increased risk of miscarriage, with reported rates ranging from 20% to 34%. Insulin resistance is a key metabolic abnormality in PCOS, potentially contributing to pregnancy loss through mitochondrial dysfunction or impaired endometrial decidualisation. While metformin improves insulin sensitivity and has been proposed to reduce miscarriage risk, evidence from randomised controlled trials remains inconclusive due to small sample sizes and variation in treatment timing. International guidelines highlight the lack of high-quality evidence, emphasising the urgent need for well-designed, adequately powered trials.
This study is a pre-specified miscarriage prevention study nested within the LOCI 2x2 factorial design randomised trial that evaluated letrozole versus clomifene, with or without metformin, for ovulation induction in women with polycystic ovary syndrome. This study investigated whether exposure to metformin through to the end of the first trimester influenced miscarriage rate compared with placebo in those women who conceived.
Women aged 18–42 years with PCOS (Rotterdam criteria)…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,739 participants or records.
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