Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women (ESLOD)

May 14, 2014 updated by: Ahmed Gibreel, Mansoura University

Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.

Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these women.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Current literature suggests that endometrial biopsy may improve pregnancy rates in infertile women hence the investigators will examine whether this hypothesis will apply to infertile PCOS women undergoing laparoscopic ovarian drilling to overcome ovulatory disfunction or not.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Mansoura, Egypt, 53111
        • Recruiting
        • Mansoura University Teaching Hospital
        • Principal Investigator:
          • Ahmed Gibreel, MD

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

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
  2. Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
  3. Patent Fallopian tubes as confirmed by hysterosalpingography
  4. Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).

Exclusion Criteria:

  1. women with BMI >30,
  2. age < 18 years or > 39 years,
  3. women with ovarian cysts identified by transvaginal ultrasound
  4. male factor infertility
  5. Tubal factor infertility as suggested by hystrosalpingogram (HSG)
  6. Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Currettage
Endometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling
Procedure: Endometrial Currettage
Only Laparoscopic ovarian drilling without endometrial currettage will be performed
Other Names:
  • Endometrial injury
  • endometrial scratching
  • Endometrial scraping
No Intervention: Nothing
No endometrial curettage at time of Laparoscopic ovarian drilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
live birth rate per woman randomized
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate per woman randomised
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
miscarriage rate time to pregnancy interval
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Mansoura University

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

April 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 92013

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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