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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014