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Endometrial Injury and IVF-ET Outcome

NCT ID: NCT00796341

Last Updated: 2008-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-09-30

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).

Conditions

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Infertility

Keywords

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invitro-fertilization ,embryo transfer,endometrial injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

PIPELLE ENDOMETRIAL SAMPLING

Intervention Type PROCEDURE

Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Endometrial sampling

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bangalore Assisted Conception Centre

OTHER

Sponsor Role lead

Responsible Party

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Bangalore Assisted Conception Centre

Principal Investigators

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SACHIN A NARVEKAR, MD

Role: PRINCIPAL_INVESTIGATOR

Bangalore Assisted Conception Centre

Locations

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Bangalore Assisted Conception Centre

Bangalore, Karnataka, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 12798877 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34110001 (View on PubMed)

Other Identifiers

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endometrial injury study

Identifier Type: -

Identifier Source: org_study_id