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

Mansoura University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt); Procedure: Laparoscopic ovarian diathermy (LOD)

Study type: Interventional

Funder types: Other

Identifiers

NCT00969631

MU- 012

FMH-009-C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 282 patients

Sex: Female

Ages: 20 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CC resistant PCOS

Exclusion criteria

• Congenital adrenal hyperplasia
• Cushing syndrome
• Androgen secreting tumors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Metformin-CC

Experimental group

Treatment:

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

Laparoscopic ovarian diathermy (LOD)

Active Comparator group

Treatment:

Procedure: Laparoscopic ovarian diathermy (LOD)