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

Infertility Clinical Trial

— ESICOHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245309
• Other study ID #: AG1001
• Status: Completed
• Phase: Phase 0
• First received: November 19, 2010
• Last updated: January 14, 2014
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• scratching
endometrial scratching before COH in IVF
• A PLACEBO PROCEDURE
A PLACEBO PROCEDURE

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate per woman		9 months	No
Secondary	ongoing pregnancy rate		12 weeks	No