Back to resultsLetrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole
Laparoscopic ovarian diathermy (LOD)
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, clomiphene resistance, letrozole, Laparoscopic ovarian diathermy
Eligibility Criteria
Inclusion Criteria:
- CC resistant PCOS
Exclusion Criteria:
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Sites / Locations
- Mansoura University Hospitals,OB/GYN department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Letrozole
Laparoscopic ovarian diathermy (LOD)
Arm Description
2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles
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.
Outcomes
Primary Outcome Measures
occurrence of ovulation and midcycle endometrial thickness (mm).
Secondary Outcome Measures
occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00956267
Brief Title
Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
Official Title
Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, clomiphene resistance, letrozole, Laparoscopic ovarian diathermy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Letrozole
Arm Type
Experimental
Arm Description
2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles
Arm Title
Laparoscopic ovarian diathermy (LOD)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian diathermy (LOD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
occurrence of ovulation and midcycle endometrial thickness (mm).
Secondary Outcome Measure Information:
Title
occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CC resistant PCOS
Exclusion Criteria:
Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD. MRCOG
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdel Maged Mashaly, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Badawy, MD.PhD.
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospitals,OB/GYN department
City
Mansoura
State/Province
Dakahlia Governorate
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
16595197
Citation
Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
Results Reference
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PubMed Identifier
14739186
Citation
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. doi: 10.1136/bmj.328.7433.192.
Results Reference
background
PubMed Identifier
17636653
Citation
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. doi: 10.1002/14651858.CD001122.pub3.
Results Reference
background
Learn more about this trial
Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
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