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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:
ClinicalTrials.gov Identifier:
NCT01245309
First Posted: November 22, 2010
Last Update Posted: January 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahmed Gibreel, Mansoura University
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.

Further study details as provided by Ahmed Gibreel, Mansoura University:

Primary Outcome Measures:
  • live birth rate per woman [ Time Frame: 9 months ]

Secondary Outcome Measures:
  • ongoing pregnancy rate [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245309


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

Responsible Party: Ahmed Gibreel, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT01245309     History of Changes
Other Study ID Numbers: AG1001
First Submitted: November 19, 2010
First Posted: November 22, 2010
Last Update Posted: January 15, 2014
Last Verified: January 2014

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