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Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278706
First Posted: January 19, 2011
Last Update Posted: January 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaplan Medical Center
  Purpose

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.


Condition Intervention
Infertility Recurrent Implantation Failure Procedure: endometrial biopsy/ies

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Timing and Number of Endometrial Biopsies in IVF Treatment and Identifying Biochemical Markers to Predict Endometrial Receptivity

Resource links provided by NLM:


Further study details as provided by Kaplan Medical Center:

Primary Outcome Measures:
  • pregnancy rates [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • live birth rates [ Time Frame: 3 years ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278706


Contacts
Contact: Dan Levin, M.D. +972-89441623 dan_l@clalit.org.il
Contact: Irit Granot, Ph.D. +972-8-9441623 irit_g@clalit.org.il

Locations
Israel
Kaplan Medical Center, IVF Unit Recruiting
Rehovot, Israel
Contact: Levin    +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.         
Weizmann Institute of Science Active, not recruiting
Rehovot, Israel
Sponsors and Collaborators
Kaplan Medical Center
  More Information

Responsible Party: Amihai Barash M.D. IVF Unit Director, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT01278706     History of Changes
Other Study ID Numbers: kmc110154CTIL
First Submitted: January 18, 2011
First Posted: January 19, 2011
Last Update Posted: January 26, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female