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Insulin Sensitizing Agent (Metformin) Improves Clinical Pregnancy Rate and Insulin Parameters in Polycystic Ovarian Syndrome Patients With Acanthosis Nigricans

ClinicalTrials.gov · COMPLETED, 2014

66 participants

Abstract

Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically, PCOS can identify during the early adolescence. Insulin resistance is a common finding in the obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition of its more common connection to obesity and insulin resistance allows for diagnosis of related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular randomized, double-blind, placebo-controlled trial . The first pharmacological approach to induction of ovulation in women with PCOS is clomiphene citrate

Conditions: Reproductive Endocrinology, Polycystic Ovarian Syndrome.

Primary outcome: Pregnancy rate.

Enrollment: 66 participants.

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: 66 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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