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NCT00837733 Clinical Trial

Endometrial Local Injury and Implantation Failure

Infertility Clinical Trial

Official title:
Endometrial Local Injury Improves the Pregnancy Rate Among Recurrent Implantation Failure Patients Undergoing IVF/ICSI

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00837733
Other study ID # 1551354
Secondary ID
Status Completed
Phase N/A
First received February 4, 2009
Last updated February 4, 2009
Start date January 2008
Est. completion date December 2008

Study information
Verified date February 2009
Source Yazd Research & Clinical Center for Infertility
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the influence of endometrial biopsy on increasing implantation rate in patients with recurrent implantation failures, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group. The results suggest that in vitro fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy outcome.

Description:

In a randomized control trial study, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group.

The implantation rate was determined as 10.9% in biopsy group compared with 3.38% in controls. Clinical pregnancy rate was significantly higher in case group than controls (27.1% and 8.9% respectively

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date December 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 39 Years
Eligibility Inclusion Criteria:

- women with recurrent implantation failure which was defined as 2-6 cycles unsuccessful of IVF-ET in which more than 10 high grade embryo were transferred

Exclusion Criteria:

- age over than 40 years old

- poor responders to ovarian stimulation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Endometrial biopsy
Endometrial biopsy was done at luteal phase on the day 21-26 of spontaneous menstrual cycles, when GnRH agonist uses begun. Endometrial samples were taken by a biopsy catheter
• Endometrial Biopsy
Biopsy catheter

Locations
Country Name City State
Iran, Islamic Republic of Research and Clinical Center for Infertility Yazd

Sponsors (2)
Lead Sponsor Collaborator
Yazd Research & Clinical Center for Infertility Yazd Medical University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate One year Yes
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