Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

Phase 2

Completed

• Conditions: Reproductive Endocrinology; Polycystic Ovarian Syndrome
• Interventions: Drug: CC; Drug: Placebo tablets; Drug: Metformin

• Registration Number: NCT02562664
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-29
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• All patients with PCOS fulfilled at least 2 out of the three criteria of Rotterdam consensus 2003

Exclusion Criteria

• liver disease
• heart or respiratory failure
• alcohol abuse
• kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CC with placebo	Placebo tablets	100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.
CC with placebo	CC	100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.
CC plus Metformin	Metformin	received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.
CC plus Metformin	CC	received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	6 months

Secondary Outcome Measures

Name	Time	Method
Fasting glucose (mg/dl)	6 months
Fasting insulin (mg/dl)	6 months