Insulin sensitizing agent improves clinical pregnancy rate and insulin resistant parameters in polycystic ovarian syndrome patients with acanthosis nigricans: a randomized controlled study

Safwat A. Salman,Tarek Farghaly ,Omar M. Shaaban,Heba Abdel Hafez ,Dalia A. Attallah,Mohammed Khairy Ali

doi:10.17077/2154-4751.1297

Safwat A. Salman, Tarek Farghaly + Show 4 more

Open Access

https://doi.org/10.17077/2154-4751.1297

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Abstract

Objective: To investigate the effect of adding metformin to clomiphene citrate (CC) in polycystic ovarian syndrome (PCOS) patients with acanthosis nigricans (AN) who were previously not responding to CC. Material and Methods: A double blinded randomized controlled trial (NCT02562664) included 66 PCOS women with acanthosis nigricans who were CC resistant (at least 3 months). Day 3 follicle stimulating hormone (FSH) level, fasting insulin, fasting glucose and homeostatic model assessment were used to quantify insulin resistance. Participants were randomly assigned to either group I (CC with placebo tablets) or group II (CC with metformin) for three cycles. Insulin resistance parameters as well as clinical pregnancy rate had been evaluated in both groups. The statistical analysis was done using Chi- square and Fischer exact tests. Results: The demographic data was comparable in both groups, however; there was higher cumulative pregnancy rate after three cycles of stimulation in group II (18/33) (54.5%) in comparison with group I (7/33) (21.1%) (P=0.03). There was a significant improvement in the insulin resistance parameters after three months of combining clomiphene citrate with metformin as compared with CC alone. Conclusion: Adding metformin to CC in clomiphene citrate resistant PCOS patients who have acanthosis nigricans improves the pregnancy rate and insulin resistant parameters.

Highlights

Polycystic ovary syndrome (PCOS) is the most common female endocrine disorder, with a prevalence ranging between 6% to 10% based on the National Institutes of Health (NIH)criteria
There was a significant improvement in the insulin resistance parameters after three months of combining clomiphene citrate with metformin as compared with CC alone
; the studied women were similar in the ovarian volume, antral follicle count (AFC), follicle stimulating hormone (FSH), LH and prolactin (Table 1)

Summary

Introduction

Polycystic ovary syndrome (PCOS) is the most common female endocrine disorder, with a prevalence ranging between 6% to 10% based on the National Institutes of Health (NIH). When the broader Rotterdam criteria are applied; the prevalence reaches as high as 15%.1. The typical presentation of POCS includes ovarian dysfunction (anovulation), hyperandrogenism (either clinical or biochemical), and the ultrasonographic picture of polycystic ovaries.[2]. The etiology of the syndrome is still unclear and the variability in clinical presentation continues to make the clinical and research implications challenging.[3]. Insulin resistance is a common finding in obese women with PCOS.[4]. The cellular and molecular mechanisms of insulin resistance in PCOS differ from other common insulin-resistant states such as obesity and type 2 diabetes mellitus (DM).[5]. PCOS and obesity both have a negative effect on insulin action.[6]

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