Metformin effects on ovarian ultrasound appearance and steroidogenic function in normal-weight normoinsulinemic women with polycystic ovary syndrome: A randomized double-blind placebo-controlled clinical trial
Open accessAbstract
Objective To investigate metformin effects on the endocrine-metabolic parameters and ovarian morphology in normoinsulinemic women with polycystic ovary syndrome (PCOS).Design Randomized double-blind study.Setting Operative Division of Endocrinological Gynecology, Università Cattolica del Sacro Cuore.Patient(s) Twenty-eight normal-weight normoinsulinemic PCOS women.Intervention(s) Patients were randomized to receive metformin 500 mg twice a day (group A, 15 subjects) or placebo (group B, 13 subjects) for 6 months. Ultrasonographic pelvic exams, hormonal and lipid features, and oral glucose tolerance test were performed at baseline and after 3 and 6 months of treatment.Main outcome measure(s) Hormonal and glycoinsulinemic assessment, ovarian ultrasound appearance.Result(s) Glycoinsulinemic assessment remained unvaried in both groups. About 70% of patients in group A experienced a restoration of menstrual cyclicity. Metformin significantly decreased testosterone levels at 3 and 6 months) and 17-hydroxyprogesterone levels at 6 months, and improved hirsutism score at 6 months. No clinical or hormonal modifications occurred in group B. Metformin, but not placebo, reduced ovarian volume and stromal/total area ratio at 3 and 6 months.Conclusion(s) Metformin seems to improve the menstrual pattern and ultrasonographic ovarian features in normoinsulinemic PCOS women. These effects seem to be, at least in part, independent of the insulin-lowering properties of the drug.
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Weight loss may reduce the prevalence of PCOM.
“Moreover, it might also reduce the prevalence of PCOM (Romualdi et al., 2010;Redman et al., 2011).”
From Improvements in PCOS characteristics and phenotype severity during a randomized controlled lifestyle intervention (2021) · cites this paper as Romualdi et al., 2010
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“These beneficial effects are, at least in part, mediated by metformin’s insulin-lowering property, which contributes to the amelioration of insulin resistance, a key pathophysiological feature in the metabolism of PCOS [108].”
- Authors
- Romualdi, D., Giuliani, M., Cristello, F., Fulghesu, A. M., Selvaggi, L., Lanzone, A., & Guido, M.
- Affiliations
- Università Cattolica del Sacro Cuore (IT)
- University of Cagliari (IT)
- Corresponding author
- Guido, Maurizio
- Venue
- Fertility and Sterility
- Publisher
- Elsevier BV
- Published
- 2010-05
- Volume
- 93
- Issue
- 7
- Pages
- 2303-2310
- ISSN
- 0015-0282 (ISSN-L)
- OpenAlex
- W1985310425
- Cited by
- 58
- References
- 46
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 2 · 2023: 4 · 2022: 4 · 2021: 5 · 2020: 7 · 2018: 1 · 2017: 4 · 2016: 1 · 2015: 5 · 2014: 3 · 2013: 4 · 2012: 4
- FWCI
- 5.89
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Fertility and Sterility (publishedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi dell Aquila (submittedVersion)
- Funders
- Ministero dell’Istruzione, dell’Università e della Ricerca
- Ministry of Public Health
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Keywords
- metformin, polycystic ovary syndrome, ovarian morphology, ovarian volume, steroidogenesis, testosterone, 17-hydroxyprogesterone, menstrual cyclicity, hirsutism, insulin resistance, oral glucose tolerance, normal-weight women
- MeSH terms
- Adult, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Insulin, Metformin, Ovary, Placebos, Polycystic Ovary Syndrome, Gonadal Steroid Hormones, Time Factors, Ultrasonography, Young Adult, Ideal Body Weight
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