Endometrial Scratching Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization With Previous IVF Failure

Early Phase 1

Completed

• Conditions: Infertility
• Interventions: Procedure: scratching; Procedure: A PLACEBO PROCEDURE

• Registration Number: NCT01245309
• Lead Sponsor: Mansoura University

Brief Summary

Scratching the linning of the womb before IVF cycle could increase the chances of having a baby after an IVF cycle.

Detailed Description

All women with history of RIF (as defined by ESHRE) and who wish to undertake another assisted conception treatment cycle are invited to participate in the trial. Women will be randomised to two arms; one undergoing endometrial sampling and control. Women in the experimental arm will be subjected to endometrial scrapping with Pipelle biopsy catheter two times; on days 21 and 26 of the cycle prior to the IVF index cycle and after initiation of the GnRHa in the long agonist protocol. Women in the control group will undergo a placebo procedure using the uterine sound on the same days of the cycle like women in the intervention group.

Study Timeline

• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Study Start: 2010-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

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

Inclusion Criteria

WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT

Exclusion Criteria

• WOMEN>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
scratching	scratching	endometrial scratching prior ivf cycle
scratching	A PLACEBO PROCEDURE	endometrial scratching prior ivf cycle
PLACEBO	A PLACEBO PROCEDURE	PLACEBO PROCEDURE

Primary Outcome Measures

Name	Time	Method
live birth rate per woman	9 months

Secondary Outcome Measures

Name	Time	Method
ongoing pregnancy rate	12 weeks

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt