Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

Study Overview
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Brief Summary
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The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).

Official Title
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Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial

Conditions
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Induction of Ovulation

Intervention / Treatment
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* Drug: group A 2.5 mg letrozole oral tablets
* Procedure: laparoscopic ovarian drilling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed as PCOS according to Roterdam (2003) criteria patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles. patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis. normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization. normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone. no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months. Exclusion Criteria: 1- Infertility induced by reasons other than PCOS. 2- uterine cavity lesions or ovarian cyst. 3- >40 years old. 4- body mass index (BMI) >26 kg/m2. 5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease. -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A Letrozole group<br>2.5 mg letrozole oral tablets will be administered on the 2nd -3rd day of menses and then every day for 5 days. | Drug: group A 2.5 mg letrozole oral tablets<br>* 2.5 mg letrozole oral tablets will be administered on the 2nd-3rd day of menses and then every day for 5 days. Treatment will be repeated for up to three cycles if the patient failed to conceive.<br>|
| Active Comparator: Group B laparoscopic ovarian drilling group<br>bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary. | Procedure: laparoscopic ovarian drilling<br>* Bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OVULATION RATE | SERUM PROGESTERON LEVEL | 7 DAYS BEFORE NEXT MENSES | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIOCHEMICAL PREGNANCY RATE | BY SERUM HCG | AFTER 30 DAYS OF INTERVENTION | 
| CLINICAL PREGNANCY RATE | BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN | AT 6 WEEKS GESTATION | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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letrozol, laparoscopic ovarian drilling