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Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

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ClinicalTrials.gov Identifier: NCT01278706
Recruitment Status : Unknown
Verified December 2010 by Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 19, 2011
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:
Kaplan Medical Center

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.


Condition or disease Intervention/treatment Phase
Infertility Recurrent Implantation Failure Procedure: endometrial biopsy/ies Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




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

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


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

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

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 Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: December 2010

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