Endometrial Local Injury and Implantation Failure

This study has been completed.
Sponsor:
Collaborator:
Yazd Medical University
Information provided by:
Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier:
NCT00837733
First received: February 4, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Infertility
Procedure: Endometrial biopsy
Procedure: Endometrial Biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Endometrial Local Injury Improves the Pregnancy Rate Among Recurrent Implantation Failure Patients Undergoing IVF/ICSI

Resource links provided by NLM:


Further study details as provided by Yazd Research & Clinical Center for Infertility:

Primary Outcome Measures:
  • Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biopsy catheter
Biopsy catheter (Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France
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
Other Name: biopsy catheter (Pipelle de Cornier, Prodimed, France
Procedure: Endometrial Biopsy
Biopsy catheter
Other Name: Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France

Detailed 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

  Eligibility

Ages Eligible for Study:   15 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837733

Locations
Iran, Islamic Republic of
Research and Clinical Center for Infertility
Yazd, Iran, Islamic Republic of, 8916877391
Sponsors and Collaborators
Yazd Research & Clinical Center for Infertility
Yazd Medical University
Investigators
Principal Investigator: Mohammad Ali Karimzadeh, Professor Research and Clinical Center for Infertility
  More Information

No publications provided

Responsible Party: Department of Obstetrics and Gynecology, Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier: NCT00837733     History of Changes
Other Study ID Numbers: 1551354
Study First Received: February 4, 2009
Last Updated: February 4, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Yazd Research & Clinical Center for Infertility:
Endometrial biopsy
IVF/ICSI
Pregnancy outcome
Recurrent implantation failure

Additional relevant MeSH terms:
Infertility
Wounds and Injuries
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 28, 2014