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

This study has been completed.

Sponsor:

Information provided by:

Mansoura University

ClinicalTrials.gov Identifier:

NCT00956267

First received: August 10, 2009

Last updated: NA

Last verified: August 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 10, 2009

Last Updated Date

August 10, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

occurrence of ovulation and midcycle endometrial thickness (mm). [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates. [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Polycystic Ovary Syndrome

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Drug: Letrozole
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.

Intervention: Procedure: Laparoscopic ovarian diathermy (LOD)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

260

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

CC resistant PCOS

Exclusion Criteria:

Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors

Gender

Female

Ages

20 Years to 36 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Egypt

Administrative Information

NCT Number ^ICMJE

NCT00956267

Other Study ID Numbers ^ICMJE

MU- 094, FMH-052-K

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University.

Study Sponsor ^ICMJE

Mansoura University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Mansoura University

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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