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

Polycystic Ovary Syndrome Clinical Trial

— MIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02498522
• Other study ID #: Metformin in pregnancy
• Status: Recruiting
• Phase: Phase 0
• First received: July 13, 2015
• Last updated: December 30, 2015
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2015
• Source: Ain Shams University
• Contact: ahmed M Kotb, MD
• Phone: 010086819990
• Email: ahmedmkotp[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
83 patients will continue metformin until end of 1st trimester

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miscarriage rate		6 months	Yes