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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPELLE ENDOMETRIAL SAMPLING | Procedure | Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; | 9 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE | 9 MONTHS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SACHIN A NARVEKAR, MD | Bangalore Assisted Conception Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangalore Assisted Conception Centre | Bangalore | Karnataka | 560001 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12798877 | Background | 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. | |
| 34110001 | Derived | Lensen 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 11, 2008 | |
| Unrelease | Yes | |
| Release | Dec 16, 2008 | |
| Reset | Jan 12, 2009 | |
| Release | Jan 14, 2009 | |
| Reset | Feb 5, 2009 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 11, 2008 | Yes | |||
| Dec 16, 2008 |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Jan 12, 2009 |
| Jan 14, 2009 | Feb 5, 2009 |