Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt); Procedure: Laparoscopic ovarian diathermy (LOD)

• Registration Number: NCT00969631
• Lead Sponsor: Mansoura University

Brief Summary

The purpose of this study is to compare and determine the efficacy of combined metformin and Clomiphene citrate administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.

Detailed Description

All patients in the combined metformin-CC group received metformin HCl (Cidophage®;Chemical Industries Development,Cairo, Egypt), 500 mg thrice daily for 6-8 weeks. Then after the end of this period, they received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of menstruation (increased by 50 mg in the next cycle in case of anovulation ). Patients continued treatment for up to six cycles. Metformin was stopped only when pregnancy was documented. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-08
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Last Update Submitted: 2009-08-31
• Study First Posted: 2009-09-01
• Last Update Posted: 2009-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 282

Inclusion Criteria

• CC resistant PCOS

Exclusion Criteria

• Congenital adrenal hyperplasia
• Cushing syndrome
• Androgen secreting tumors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin-CC	metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt)	-
Laparoscopic ovarian diathermy (LOD)	Laparoscopic ovarian diathermy (LOD)	-

Primary Outcome Measures

Name	Time	Method
occurrence of ovulation and midcycle endometrial thickness (mm).

Secondary Outcome Measures

Name	Time	Method
occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.

Trial Locations

Locations (1)

Mansoura University Hospitals, OB/GYN department; 🇪🇬 Mansoura, Dakahlia Governorate, Egypt