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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ahmed Gibreel, Mansoura University
ClinicalTrials.gov Identifier:
NCT01245309
First received: November 19, 2010
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Infertility
Procedure: scratching
Procedure: A PLACEBO PROCEDURE
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Injury Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization in Women With Previous IVF Failure.

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • live birth rate per woman [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ongoing pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: scratching
endometrial scratching prior ivf cycle
Procedure: scratching
endometrial scratching before COH in IVF
Procedure: A PLACEBO PROCEDURE
A PLACEBO PROCEDURE
Placebo Comparator: PLACEBO
PLACEBO PROCEDURE
Procedure: A PLACEBO PROCEDURE
A PLACEBO PROCEDURE

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.

  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT

-

Exclusion Criteria:

  • WOMEN>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245309

Locations
Egypt
Mansoura University
Mansoura, Egypt, 53111
Sponsors and Collaborators
Mansoura University
  More Information

No publications provided

Responsible Party: Ahmed Gibreel, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT01245309     History of Changes
Other Study ID Numbers: AG1001
Study First Received: November 19, 2010
Last Updated: January 14, 2014
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014