Metformin versus N-acetylcysteine Combined with Clomiphene Citrate for Improving Insulin Resistance in Infertile Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial
Abstract
Polycystic ovary syndrome (PCOS) is a common endocrine disorder and insulin resistance (IR) is central to its pathogenesis. Although metformin is widely used as an insulin sensitizer, gastrointestinal adverse effects may limit adherence. N-acetylcysteine (NAC), having insulin-sensitizing properties, has emerged as a potential alternative, but comparative evidence remains limited.
To compare the efficacy of NAC and metformin, each combined with clomiphene citrate, on IR, hormonal and metabolic profiles, oxidative stress, ovulation, and pregnancy outcomes in infertile women with PCOS.
In this randomized, single-blind controlled trial, 169 infertile women with PCOS were randomized to receive NAC (600 mg three times daily) or metformin (500 mg three times daily), each combined with clomiphene citrate for 6 months. The primary outcome was change in 2-h postglucose serum insulin. Secondary outcomes included ovulation, clinical pregnancy, hormonal and metabolic parameters, oxidative stress and adverse events.
Of 343 women screened, 169 were randomized; 166 completed the study. Both treatments significantly improved glucose metabolism, IR, lipid profile, oxidative stress, and ovulation. Metformin produced greater reductions in Luteinizing hormone, testosterone, and 2-h postglucose insulin than NAC (28.48 vs. 16.64 µIU/mL;
P
= 0.037). Clinical pregnancy rates were higher with metformin (34.9% vs. 22.9%), although the difference was not statistically significant. No serious adverse…
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: 343 participants or records.
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