Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

May 6, 2022 updated by: Ahmed Mohamed Abbas, Assiut University

Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University
        • Contact:
          • Ahmed Abbas, MD
          • Phone Number: 00201003385183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ovulation rate
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The mid-cyclic endometrial thickness
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2017

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

January 1, 2017

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEVOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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