Endometrial Injury and IVF-ET Outcome

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: PIPELLE ENDOMETRIAL SAMPLING


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: PIPELLE ENDOMETRIAL SAMPLING<br>* Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.<br>* Other names: Endometrial sampling;|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; |  | 9 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE |  | 9 MONTHS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invitro-fertilization ,embryo transfer,endometrial injury