Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin; Other: Placebo

• Registration Number: NCT02910817
• Lead Sponsor: Assiut University

Brief Summary

RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-12
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

• The inclusion criteria restricted the patients to 39 years old with basal FSH < 10 IU/ml and normal TSH and prolacin.

Exclusion Criteria

• Exclusion criteria were diabetes mellitus (excluded by GTT), renal or liver disease, associated male factor, documented tubal factor or pelvic adhesions, elevated 17 alfa hydroxyprogesterone level and FSH ≥10 IU/ml. We also excluded the women who started program or medications to reduce their weight and those who their partner has abnormal semen parameters according to the world health organization parameters (WHO, 2010)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin-treated group	Metformin	51 overweight and obese women (BMI\>24) with PCOS underwent their first fresh autologous IVF-embryo transfer cycle
Placebo	Placebo	A cohort of fifty-one cross matched PCOS women

Primary Outcome Measures

Name	Time	Method
Total number of retrieved oocytes	Two weeks Metformin treatment

Secondary Outcome Measures

Name	Time	Method
Live birth rate	End of the pregnancy

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt