Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Letrozole
* Procedure: Laparoscopic ovarian diathermy (LOD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CC resistant PCOS Exclusion Criteria: Congenital adrenal hyperplasia Cushing syndrome Androgen secreting tumors

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole<br>2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles | Drug: Letrozole<br>* 2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles<br>|
| Active Comparator: Laparoscopic ovarian diathermy (LOD)<br>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. | Procedure: Laparoscopic ovarian diathermy (LOD)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of ovulation and midcycle endometrial thickness (mm). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic ovary syndrome, clomiphene resistance, letrozole, Laparoscopic ovarian diathermy