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

Primary Purpose

Infertility, Polycystic Ovarian Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Endometrial Currettage
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, PCOS, scratching, endometrial receptivity

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Currettage

Nothing

Arm Description

Endometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling

No endometrial curettage at time of Laparoscopic ovarian drilling

Outcomes

Primary Outcome Measures

live birth rate per woman randomized

Secondary Outcome Measures

pregnancy rate per woman randomised

Full Information

First Posted
April 25, 2014
Last Updated
May 14, 2014
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02140398
Brief Title
Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women
Acronym
ESLOD
Official Title
Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Polycystic Ovarian Syndrome
Keywords
infertility, PCOS, scratching, endometrial receptivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Currettage
Arm Type
Experimental
Arm Description
Endometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling
Arm Title
Nothing
Arm Type
No Intervention
Arm Description
No endometrial curettage at time of Laparoscopic ovarian drilling
Intervention Type
Procedure
Intervention Name(s)
Endometrial Currettage
Other Intervention Name(s)
Endometrial injury, endometrial scratching, Endometrial scraping
Intervention Description
Only Laparoscopic ovarian drilling without endometrial currettage will be performed
Primary Outcome Measure Information:
Title
live birth rate per woman randomized
Time Frame
15 months
Secondary Outcome Measure Information:
Title
pregnancy rate per woman randomised
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
miscarriage rate time to pregnancy interval
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS). Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins Patent Fallopian tubes as confirmed by hysterosalpingography Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010). Exclusion Criteria: women with BMI >30, age < 18 years or > 39 years, women with ovarian cysts identified by transvaginal ultrasound male factor infertility Tubal factor infertility as suggested by hystrosalpingogram (HSG) Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Gibreel, MD
Phone
00201004045733
Email
ahmedfathgi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Gibreel, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Teaching Hospital
City
Mansoura
ZIP/Postal Code
53111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Gibreel, MD

12. IPD Sharing Statement

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Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women

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