Back to resultsEndometrial Scratching Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization With Previous IVF Failure (ESICOHF)
Primary Purpose
Infertility
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
scratching
A PLACEBO PROCEDURE
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT
-
Exclusion Criteria:
- WOMEN>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
scratching
PLACEBO
Arm Description
endometrial scratching prior ivf cycle
PLACEBO PROCEDURE
Outcomes
Primary Outcome Measures
live birth rate per woman
Secondary Outcome Measures
ongoing pregnancy rate
Full Information
NCT ID
NCT01245309
First Posted
November 19, 2010
Last Updated
January 14, 2014
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT01245309
Brief Title
Endometrial Scratching Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization With Previous IVF Failure
Acronym
ESICOHF
Official Title
Endometrial Injury Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization in Women With Previous IVF Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
scratching
Arm Type
Experimental
Arm Description
endometrial scratching prior ivf cycle
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
PLACEBO PROCEDURE
Intervention Type
Procedure
Intervention Name(s)
scratching
Intervention Description
endometrial scratching before COH in IVF
Intervention Type
Procedure
Intervention Name(s)
A PLACEBO PROCEDURE
Intervention Description
A PLACEBO PROCEDURE
Primary Outcome Measure Information:
Title
live birth rate per woman
Time Frame
9 months
Secondary Outcome Measure Information:
Title
ongoing pregnancy rate
Time Frame
12 weeks
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT
-
Exclusion Criteria:
WOMEN>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
53111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Endometrial Scratching Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization With Previous IVF Failure
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