Study to Compare Between Combimed Metformin-letrozole and Ovarian Drilling in Pcos With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome

Phase 1

Completed

• Conditions: Focus of Study
• Interventions: Drug: metformin plus letrozole; Procedure: ovarian drilling

• Registration Number: NCT01693289
• Lead Sponsor: Zagazig University

Brief Summary

the study compare the hormonal-metabolic and reproductive outcome between combined metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic syndrome

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-23
• Study First Submitted QC: 2012-09-25
• Last Update Submitted: 2012-09-25
• Study First Posted: 2012-09-26
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

• polycystic ovary syndrome
• infertility
• clomiphene citrate resistance

Exclusion Criteria

• women with other causes of infertility as male factor or tubal factor, those with endocrine disorders as thyroid dysfunction and hyperprolactinemia women who received hormonal treatment or ovulation induction drugs 3 months prior to the study
• pregnancy during follow up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin plus letrozole	metformin plus letrozole	metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle
ovarian drilling	ovarian drilling	bilateral diathermy ovarian drilling, four drills each ovary

Primary Outcome Measures

Name	Time	Method
hormonal and metabolic changes	6 months

Secondary Outcome Measures

Name	Time	Method
reproductive outcome	6months

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt