Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

NCT ID: NCT02562664

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-07-31

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

Conditions

Reproductive Endocrinology; Polycystic Ovarian Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CC with placebo

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.

Group Type: ACTIVE_COMPARATOR

CC

Intervention Type: DRUG

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle

Placebo tablets

Intervention Type: DRUG

Placebo tablets taken twice daily continuously for three cycles.

CC plus 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.

Group Type: ACTIVE_COMPARATOR

CC

Intervention Type: DRUG

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle

Metformin

Intervention Type: DRUG

wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.

Interventions

CC

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle

Intervention Type: DRUG

Placebo tablets

Placebo tablets taken twice daily continuously for three cycles.

Intervention Type: DRUG

Metformin

wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MPCOS

Identifier Type: -

Identifier Source: org_study_id