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

Early Phase 1

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin

• Registration Number: NCT02498522
• Lead Sponsor: Ain Shams University

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-15
• Study Start: 2015-08
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Results First Submitted: 2016-03-28
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-13
• Last Update Submitted: 2016-04-13
• Results First Posted: 2016-05-19
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	Metformin	83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
metformin arm	Metformin	83 patients will continue metformin until end of 1st trimester (14 weeks gestation)

Primary Outcome Measures

Name	Time	Method
Miscarriage Rate	6 months

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Al Qahirah, Egypt