Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Kaplan Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Kaplan Medical Center
ClinicalTrials.gov Identifier:
NCT01278706
First received: January 18, 2011
Last updated: January 25, 2011
Last verified: December 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • live birth rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Amihai Barash M.D. IVF Unit Director, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT01278706     History of Changes
Other Study ID Numbers: kmc110154CTIL
Study First Received: January 18, 2011
Last Updated: January 25, 2011
Health Authority: Israel: Clalit Health Services

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

ClinicalTrials.gov processed this record on April 16, 2014