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

April 13, 2016 updated by: Islam Dabbous, Ain Shams University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

166

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt
        • Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metformin arm
83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
Drug: Metformin
83 patients will continue metformin until end of 1st trimester
Other Names:
  • cidophage
Placebo Comparator: control arm
83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Drug: Metformin
83 patients will continue metformin until end of 1st trimester
Other Names:
  • cidophage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Miscarriage Rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed M kotb, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metformin in pregnancy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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