Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

January 25, 2011 updated by: Kaplan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Rehovot, Israel
        • Kaplan Medical Center, IVF Unit
        • Contact:
          • Levin
          • Phone Number: +972-8-9441623
        • Principal Investigator:
          • Amihai Barash, M/D/
        • Sub-Investigator:
          • Dan Levin, M.D.
        • Sub-Investigator:
          • Yuval Or, M.D.
        • Sub-Investigator:
          • Irit Granot, Ph.D.
      • Rehovot, Israel
        • Weizmann Institute of Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no treatment
Experimental: one biopsy, proliferative phase
Procedure: endometrial biopsy/ies
performing office endometrial biopsy with a disposable sterile catheter
Experimental: one biopsy, secretory phase
Procedure: endometrial biopsy/ies
performing office endometrial biopsy with a disposable sterile catheter
Experimental: two biopsies
Procedure: endometrial biopsy/ies
performing office endometrial biopsy with a disposable sterile catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy rates
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
live birth rates
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaplan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kmc110154CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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