Endometrial Injury and IVF-ET Outcome
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; [ Time Frame: 9 MONTHS ] [ Designated as safety issue: No ]
- CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE [ Time Frame: 9 MONTHS ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Procedure: PIPELLE ENDOMETRIAL SAMPLING
Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.
Other Name: Endometrial sampling
|No Intervention: 2|
Study Design and Subjects: This is a randomized control study designed to evaluate the effect of local injury to the endometrium in non-transfer cycle in patients with previous failed IVF.
Patients will be randomly allotted to control and intervention group The patients in the intervention group Pipelle endometrial sampling 7-10th day and 24-26th day in the cycle prior to IVF transfer cycle.
Outcome Measures: Clinical pregnancy rate,implantation rate and ongoing pregnancy rate.
SAMPLE SIZE: 100 PATIENTS (50 in each group).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796341
|Bangalore Assisted Conception Centre|
|Bangalore, Karnataka, India, 560001|
|Principal Investigator:||SACHIN A NARVEKAR, MD||Bangalore Assisted Conception Centre|