Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
Not Applicable
Completed
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Procedure: Laparoscopic ovarian diathermy (LOD)
- Registration Number
- NCT00956267
- Lead Sponsor
- Mansoura University
- Brief Summary
The purpose of this study is to compare and determine the efficacy of letrozole 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
In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 260
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 Laparoscopic ovarian diathermy (LOD) 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. Letrozole Letrozole 2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles
- 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