ESLOD: Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women

Sponsor

Mansoura University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02140398

Collaborator

(none)

500

Enrollment

Location

Arms

Duration (Months)

27.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Polycystic Ovarian Syndrome	Procedure: Endometrial Currettage	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

live birth rate per woman randomized [15 months]

Secondary Outcome Measures

pregnancy rate per woman randomised [6 months]

Other Outcome Measures

miscarriage rate time to pregnancy interval [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.