Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome. - Full Text View

Purpose

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	Intervention
Polycystic Ovary Syndrome	Drug: Letrozole Procedure: Laparoscopic ovarian diathermy (LOD)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Polycystic Ovary Syndrome

Drug Information available for: Clomiphene Letrozole

U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	260
Study Start Date:	August 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	20 Years to 36 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CC resistant PCOS

Exclusion Criteria:

Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956267

Locations

Egypt
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 Hospitals
Study Director:	Abdel Maged Mashaly, MD	Mansoura University Hospitals
Study Chair:	Ahmed Badawy, MD.PhD.	Mansoura University Hospitals

More Information

Publications:

Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. Review.

Bayram N, van Wely M, Kaaijk EM, Bossuyt PM, van der Veen F. Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial. BMJ. 2004 Jan 24;328(7433):192.

Farquhar C, Lilford RJ, Marjoribanks J, Vandekerckhove P. Laparoscopic 'drilling' by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122. Review.

Responsible Party:	Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University.
ClinicalTrials.gov Identifier:	NCT00956267 History of Changes
Other Study ID Numbers:	MU- 094, FMH-052-K
Study First Received:	August 10, 2009
Last Updated:	August 10, 2009
Health Authority:	Egypt: Institutional Review Board

Keywords provided by Mansoura University:

Polycystic ovary syndrome
clomiphene resistance
letrozole
Laparoscopic ovarian diathermy

Additional relevant MeSH terms:

Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders

Endocrine System Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013