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

M

Mansoura University

Status

Completed

Conditions

Polycystic Ovary Syndrome

Treatments

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

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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