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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT00969631

Collaborator

(none)

282

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt) Procedure: Laparoscopic ovarian diathermy (LOD)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

282 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Combined Metformin and Clomiphene Citrate Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metformin-CC	Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt) metformin HCl 1500 daily for 6-8 weeks then 100 mg CC for 5 days starting from day 3 of menstruation up to 6 cycles.
Active Comparator: Laparoscopic ovarian diathermy (LOD)	Procedure: Laparoscopic ovarian diathermy (LOD) Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.

Arm

Intervention/Treatment

Experimental: Metformin-CC

Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt)

metformin HCl 1500 daily for 6-8 weeks then 100 mg CC for 5 days starting from day 3 of menstruation up to 6 cycles.

Active Comparator: Laparoscopic ovarian diathermy (LOD)

Procedure: Laparoscopic ovarian diathermy (LOD)

Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.

Outcome Measures

Primary Outcome Measures

occurrence of ovulation and midcycle endometrial thickness (mm). []

Secondary Outcome Measures

occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 36 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

CC resistant PCOS

Exclusion Criteria:

Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitals, OB/GYN department	Mansoura	Dakahlia Governorate	Egypt

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Hatem Abu Hashim, MD. MRCOG, Mansoura University Hospital
Study Director: Naser El Lakany, MD, Mansoura University Hospital
Study Chair: Lotfi Sherief, MD, Mansoura University Hospital