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


N/A
20 Years
36 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

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


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.


Inclusion Criteria:



- CC resistant PCOS

Exclusion Criteria:

- Congenital adrenal hyperplasia

- Cushing syndrome

- Androgen secreting tumors

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

occurrence of ovulation and midcycle endometrial thickness (mm).

Safety Issue:

No

Principal Investigator

Hatem Abu Hashim, MD. MRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mansoura University Hospitals

Authority:

Egypt: Institutional Review Board

Study ID:

MU- 012

NCT ID:

NCT00969631

Start Date:

September 2005

Completion Date:

February 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic ovary syndrome
  • clomiphene resistance
  • metformin
  • laparoscopic ovarian diathermy
  • Polycystic Ovary Syndrome

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