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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT00956267

Collaborator

(none)

260

Enrollment

Location

Arms

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Letrozole Procedure: Laparoscopic ovarian diathermy (LOD)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Letrozole 2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles	Drug: Letrozole 2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles
Active Comparator: 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.	Procedure: 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.

Arm

Intervention/Treatment

Experimental: Letrozole

2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles

Drug: Letrozole

2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles

Active Comparator: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

occurrence of ovulation and midcycle endometrial thickness (mm). []

Secondary Outcome Measures

occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 36 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

CC resistant PCOS

Exclusion Criteria:

Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia Governorate	Egypt	35511

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Hatem Abu Hashim, MD. MRCOG, Mansoura University Hospital
Study Director: Abdel Maged Mashaly, MD, Mansoura University Hospital
Study Chair: Ahmed Badawy, MD.PhD., Mansoura University Hospital