Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women

Phase 4

• Conditions: Infertility; Polycystic Ovarian Syndrome
• Interventions: Procedure: Endometrial Currettage

• Registration Number: NCT02140398
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-25
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-14
• Last Update Submitted: 2014-05-14
• Study First Posted: 2014-05-16
• Last Update Posted: 2014-05-16
• Primary Completion: 2015-09
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
live birth rate per woman randomized	15 months

Secondary Outcome Measures

Name	Time	Method
pregnancy rate per woman randomised	6 months

Trial Locations

Locations (1)

Mansoura University Teaching Hospital; 🇪🇬 Mansoura, Egypt