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Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

Primary Purpose

Infertility, Recurrent Implantation Failure

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

endometrial biopsy/ies

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

normal menstrual cycle
between 1-6 previous failed IVF cycles
normal hormonal profile

Exclusion Criteria:

intrauterine procedure in last 3 months
hydrosalpinx
intrauterine lesion /malformation

Sites / Locations

Kaplan Medical Center, IVF Unit
Weizmann Institute of Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

no treatment

one biopsy, proliferative phase

one biopsy, secretory phase

two biopsies

Arm Description

Outcomes

Primary Outcome Measures

pregnancy rates

Secondary Outcome Measures

live birth rates

Full Information

NCT ID

NCT01278706

First Posted

January 18, 2011

Last Updated

January 25, 2011

Sponsor

Kaplan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01278706

Brief Title

Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

Official Title

Comparing Timing and Number of Endometrial Biopsies in IVF Treatment and Identifying Biochemical Markers to Predict Endometrial Receptivity

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Kaplan Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal time of performing the biopsy is yet to be established. In this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the treatment.

6. Conditions and Keywords

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

Infertility, Recurrent Implantation Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

no treatment

Arm Type

No Intervention

Arm Title

one biopsy, proliferative phase

Arm Type

Experimental

Arm Title

one biopsy, secretory phase

Arm Type

Experimental

Arm Title

two biopsies

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

endometrial biopsy/ies

Intervention Description

performing office endometrial biopsy with a disposable sterile catheter

Primary Outcome Measure Information:

Title

pregnancy rates

Time Frame

2 years

Secondary Outcome Measure Information:

Title

live birth rates

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: normal menstrual cycle between 1-6 previous failed IVF cycles normal hormonal profile Exclusion Criteria: intrauterine procedure in last 3 months hydrosalpinx intrauterine lesion /malformation

Central Contact Person:

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

Dan Levin, M.D.

Phone

+972-89441623

dan_l@clalit.org.il

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

Irit Granot, Ph.D.

Phone

+972-8-9441623

irit_g@clalit.org.il

Facility Information:

Facility Name

Kaplan Medical Center, IVF Unit

City

Rehovot

Country

Israel

Facility Contact: