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Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03009838
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
78.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome
Actual Study Start Date :
Jan 2, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: letrozole

letrozole 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

Drug: Letrozole
oral tablets 2.5 mg
Other Names:
  • femara

    		•
    Active Comparator: laparoscopic drilling

    laparoscopy 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

    Procedure: ovarian drilling
    laparoscopic electrocauterization

    Outcome Measures

    Primary Outcome Measures

    1. The ovulation rate [3 months]

    Secondary Outcome Measures

    1. The mid-cyclic endometrial thickness [one day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed Abbas, Dr., Assiut University
    ClinicalTrials.gov Identifier:
    NCT03009838
    Other Study ID Numbers:
    • LEVOD
    First Posted:
    Jan 4, 2017
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Infertility
    Letrozole

    Study Results

    No Results Posted as of May 9, 2022