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Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Phase 3
Conditions
Infertility
Interventions
Procedure: ovarian drilling
Registration Number
NCT03009838
Lead Sponsor
Assiut University
Brief Summary

Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
150
Inclusion Criteria
  • History of at least one year of infertility either primary or secondary.
  • Body mass index: 25-35
  • Normal fallopian tubes
  • Normal semen analysis of the husband
  • Women who will accept to participate in the study
Exclusion Criteria
  • Body mass index above 35
  • Contraindication to general anesthesia
  • Previous laparoscopic drilling
  • Presence of other causes of infertility
  • Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months
  • Women who intended to start a diet program
  • Women who will refuse to participate in the study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
letrozoleLetrozoleletrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day
laparoscopic drillingovarian drillinglaparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle
Primary Outcome Measures
NameTimeMethod
The ovulation rate3 months
Secondary Outcome Measures
NameTimeMethod
The mid-cyclic endometrial thicknessone day

Trial Locations

Locations (1)

Assiut University

🇪🇬

Assiut, Egypt

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