Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

Assiut University

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovarian Syndrome; Reproductive Endocrinology

Treatments: Drug: Metformin; Drug: Placebo tablets; Drug: CC

Study type: Interventional

Funder types: Other

Identifiers

NCT02562664

MPCOS

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

66 participants in 2 patient groups

CC with placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo tablets

Drug: CC

CC plus Metformin

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin

Drug: CC