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Factor V Leiden Mutation and Implantation Failure

This study has been completed.

Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194350
  Purpose

The purpose of this study is to determine whether inherited thrombophilias (tendency toward blood clotting) increase the risk of failure of the embryo to implant in IVF. The specific condition to be studied is the presence or absence of the Leiden mutation of the Factor V gene.


Condition Intervention
Infertility
Procedure: Test for Factor V Leiden gene mutation

Genetics Home Reference related topics:   factor V Leiden thrombophilia   

MedlinePlus related topics:   Infertility   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Retrospective
Official Title:   Evaluation of the Role of Factor V Leiden Mutation in Implantation Failure

Further study details as provided by University of Pennsylvania:

Estimated Enrollment:   399
Study Start Date:   September 2001
Study Completion Date:   August 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Women undergoing in vitro fertilization with successful ovarian hyperstimulation, oocyte retrieval, and fertilization
  • Transfer of at least 2 fresh embryos of Grade 2 (preembryo with blastomeres of equal size and <=10% cytoplasmic fragmentation) or better

Exclusion Criteria:

  • Infertility due to uterine anatomic defect
  • Current use of anticoagulant medication, such as heparin or aspirin
  • Known presence of any other condition associated with increased risk of thrombosis
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194350

Locations
United States, Pennsylvania
University of Pennsylvania Reproductive Research Unit    
      Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators
University of Pennsylvania

Investigators
Principal Investigator:     Kurt T Barnhart, MD, MSCE     University of Pennsylvania    
  More Information


Responsible Party:   University of Pennsylvania ( Kurt T Barnhart, MD, MSCE )
Study ID Numbers:   704111
First Received:   September 13, 2005
Last Updated:   July 26, 2008
ClinicalTrials.gov Identifier:   NCT00194350
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Infertility  
Factor V Leiden  

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Factor V Leiden thrombophilia
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 10, 2008




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