Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
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...
Brief Summary
Official Title: “Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: March 2009
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 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.
Outcome Measures for this Clinical Trial
Primary Measures
- occurrence of ovulation and midcycle endometrial thickness (mm).
- Safety Issue?: No
Secondary Measures
- occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- CC resistant PCOS
Exclusion Criteria:
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 36 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Mansoura University Other
Overall Clinical Trial Officials and Contacts
Hatem Abu Hashim, MD. MRCOG Principal Investigator Mansoura University Hospitals
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00956267
Study ID Number: MU- 094
ClinicalTrials.gov Identifier: NCT00956267
Health Authority: Egypt: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00956267
