Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women

Infertility Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02140398
• Other study ID #: 92013
• Status: Recruiting
• Phase: Phase 4
• First received: April 25, 2014
• Last updated: May 14, 2014
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2014
• Source: Mansoura University
• Contact: Ahmed Gibreel, MD
• Phone: 00201004045733
• Email: ahmedfathgi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome

Intervention

Procedure:
• Endometrial Currettage
Only Laparoscopic ovarian drilling without endometrial currettage will be performed

Locations

Country	Name	City	State
Egypt	Mansoura University Teaching Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	miscarriage rate time to pregnancy interval		6 months	Yes
Primary	live birth rate per woman randomized		15 months	No
Secondary	pregnancy rate per woman randomised		6 months	No