Factor V Leiden Mutation and Implantation Failure

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194350
First received: September 13, 2005
Last updated: August 8, 2011
Last verified: August 2011
  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

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

Resource links provided by NLM:


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
Sampling Method:   Non-Probability Sample
Study Population

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

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
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: 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

No publications provided

Responsible Party: Kurt T Barnhart, MD, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194350     History of Changes
Other Study ID Numbers: 704111
Study First Received: September 13, 2005
Last Updated: August 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Infertility
Factor V Leiden

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

ClinicalTrials.gov processed this record on September 18, 2014