Endometrial Injury and IVF-ET Outcome
Does Endometrial Injury in the Non-Transfer Cycle Improve the IVF-ET Outcome in the Subsequent Cycle in Patients With Previous Failed IVF Cycles: A Randomized Control Trial
1 other identifier
interventional
99
1 country
1
Brief Summary
Implantation of the human embryo is the limiting factor in the success of invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in the subsequent cycle.We believe that the injury created causes release of substances which help in implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 21, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedDecember 2, 2008
November 1, 2008
10 months
November 21, 2008
December 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;
9 MONTHS
Secondary Outcomes (1)
CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE
9 MONTHS
Study Arms (2)
1
EXPERIMENTAL2
NO INTERVENTIONInterventions
Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.
Eligibility Criteria
You may qualify if:
- Previous failed In-vitro fertilization embryo transfer cycle
- Patients who are good responders and have good quality embryos in the previous attempts
- Age of patients upto 37yrs
You may not qualify if:
- Those detected to have endometrial tuberculosis in the past, including those treated with Antituberculosis treatment
- Those with intramural fibroid distorting the endometrial cavity/sub-mucous myoma
- Those with sonographically detected hydrosalpinx
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bangalore Assisted Conception Centre
Bangalore, Karnataka, 560001, India
Related Publications (2)
Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
PMID: 12798877BACKGROUNDLensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
PMID: 34110001DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SACHIN A NARVEKAR, MD
Bangalore Assisted Conception Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 21, 2008
First Posted
November 24, 2008
Study Start
November 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 2, 2008
Record last verified: 2008-11