Endometrial Local Injury and Implantation Failure

NCT ID: NCT00837733

Last Updated: 2009-02-05

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

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to evaluate the influence of endometrial biopsy on increasing implantation rate in patients with recurrent implantation failures, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group. The results suggest that in vitro fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy outcome.

Detailed Description

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In a randomized control trial study, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group.

The implantation rate was determined as 10.9% in biopsy group compared with 3.38% in controls. Clinical pregnancy rate was significantly higher in case group than controls (27.1% and 8.9% respectively

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Biopsy catheter

Biopsy catheter (Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France

Group Type EXPERIMENTAL

Endometrial biopsy

Intervention Type PROCEDURE

Endometrial biopsy was done at luteal phase on the day 21-26 of spontaneous menstrual cycles, when GnRH agonist uses begun. Endometrial samples were taken by a biopsy catheter

Endometrial Biopsy

Intervention Type PROCEDURE

Biopsy catheter

Interventions

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Endometrial biopsy

Endometrial biopsy was done at luteal phase on the day 21-26 of spontaneous menstrual cycles, when GnRH agonist uses begun. Endometrial samples were taken by a biopsy catheter

Intervention Type PROCEDURE

Endometrial Biopsy

Biopsy catheter

Intervention Type PROCEDURE

Other Intervention Names

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biopsy catheter (Pipelle de Cornier, Prodimed, France Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France

Eligibility Criteria

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Inclusion Criteria

* women with recurrent implantation failure which was defined as 2-6 cycles unsuccessful of IVF-ET in which more than 10 high grade embryo were transferred

Exclusion Criteria

* age over than 40 years old
* poor responders to ovarian stimulation
Minimum Eligible Age

15 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yazd Medical University

OTHER

Sponsor Role collaborator

Yazd Research & Clinical Center for Infertility

OTHER

Sponsor Role lead

Responsible Party

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Yazd Research & Clinical Center for Infertility

Principal Investigators

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Mohammad Ali Karimzadeh, Professor

Role: PRINCIPAL_INVESTIGATOR

Research and Clinical Center for Infertility

Locations

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Research and Clinical Center for Infertility

Yazd, Yazd Province, Iran

Site Status

Countries

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Iran

References

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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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1551354

Identifier Type: -

Identifier Source: org_study_id

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