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NCT01278706 Clinical Trial

Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

Infertility Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01278706
Other study ID # kmc110154CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 18, 2011
Last updated January 25, 2011
Start date January 2011

Study information
Verified date December 2010
Source Kaplan Medical Center
Contact Dan Levin, M.D.
Phone +972-89441623
Email dan_l@clalit.org.il
Is FDA regulated No
Health authority Israel: Clalit Health Services
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 38 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• endometrial biopsy/ies
performing office endometrial biopsy with a disposable sterile catheter

Locations
Country Name City State
Israel Kaplan Medical Center, IVF Unit Rehovot
Israel Weizmann Institute of Science Rehovot

Sponsors (1)
Lead Sponsor Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary pregnancy rates 2 years No
Secondary live birth rates 3 years No
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