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Endometrial Sampling (Pipelle)in IVF Patients

Primary Purpose

Infertility

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Pipelle (Endometrial Sampling)

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women undergoing IVF treatment
Repeated Implantation failure

Exclusion Criteria:

PID or suspected PID
Undiagnosed Irregular Bleeding

Sites / Locations

IVF Unit, Sheba Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00411021

First Posted

December 12, 2006

Last Updated

December 12, 2006

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00411021

Brief Title

Endometrial Sampling (Pipelle)in IVF Patients

Official Title

Endometrial Sampling (Pipelle)in IVF Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Sheba Medical Center

4. Oversight

5. Study Description

Brief Summary

A prospective cross-over randomized study aimed to test the hypothesis that local injury of the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the women will continue for another IVF cycle, preceded by endometrial or cervical scratch complimentary to their procedure in the first cycle. The main major outcomes will include pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and embryo quality.

6. Conditions and Keywords

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

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

70 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Pipelle (Endometrial Sampling)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women undergoing IVF treatment Repeated Implantation failure Exclusion Criteria: PID or suspected PID Undiagnosed Irregular Bleeding

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Micha Baum, MD

baumdr@zahav.net.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Micha Baum, MD

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

IVF Unit, Sheba Medical Center

City

Ramat-Gan

ZIP/Postal Code

52621

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Micha Baum, MD

baumdr@zahav.net.il

12. IPD Sharing Statement

Learn more about this trial

Endometrial Sampling (Pipelle)in IVF Patients

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