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

NCT ID: NCT02498522

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-03-31

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

metformin arm

83 patients will continue metformin until end of 1st trimester (14 weeks gestation)

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

83 patients will continue metformin until end of 1st trimester

control arm

83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)

Group Type: PLACEBO_COMPARATOR

Metformin

Intervention Type: DRUG

83 patients will continue metformin until end of 1st trimester

Interventions

Metformin

83 patients will continue metformin until end of 1st trimester

Intervention Type: DRUG

Other Intervention Names

cidophage

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Islam Dabbous

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M kotb, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

Metformin in pregnancy

Identifier Type: -

Identifier Source: org_study_id