Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome

Early Phase 1CompletedNCT02498522

Ain Shams University166 enrolled

Overview

The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility * The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS * Research question: In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss? -Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

166

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminDRUG

83 patients will continue metformin until end of 1st trimester

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age : 25 - 35. * Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria ) * At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination. * Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations. * Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking. * Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy. Exclusion Criteria: * patients with other causes of infertility other than PCOS * contraindications to metformin : liver impairment , renal failure. * Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.

Locations (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

Miscarriage Rate

Time frame: 6 months

Data from ClinicalTrials.gov

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