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Endometrial Local Injury and Implantation Failure

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Endometrial biopsy

Endometrial Biopsy

About this trial

This is an interventional treatment trial for Infertility focused on measuring Endometrial biopsy, IVF/ICSI, Pregnancy outcome, Recurrent implantation failure

Eligibility Criteria

15 Years - 39 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Research and Clinical Center for Infertility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy catheter

Arm Description

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

Outcomes

Primary Outcome Measures

Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00837733

First Posted

February 4, 2009

Last Updated

February 4, 2009

Sponsor

Yazd Research & Clinical Center for Infertility

Collaborators

Yazd Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00837733

Brief Title

Endometrial Local Injury and Implantation Failure

Official Title

Endometrial Local Injury Improves the Pregnancy Rate Among Recurrent Implantation Failure Patients Undergoing IVF/ICSI

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Yazd Research & Clinical Center for Infertility

Collaborators

Yazd Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Endometrial biopsy, IVF/ICSI, Pregnancy outcome, Recurrent implantation failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biopsy catheter

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Endometrial biopsy

Other Intervention Name(s)

biopsy catheter (Pipelle de Cornier, Prodimed, France

Intervention Description

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

Intervention Name(s)

Endometrial Biopsy

Other Intervention Name(s)

Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France

Intervention Description

Biopsy catheter

Primary Outcome Measure Information:

Title

Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate

Time Frame

One year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad Ali Karimzadeh, Professor

Organizational Affiliation

Research and Clinical Center for Infertility

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research and Clinical Center for Infertility

City

Yazd

ZIP/Postal Code

8916877391

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

34110001

Citation

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.

Results Reference

derived

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Endometrial Local Injury and Implantation Failure

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