Factor V Leiden Mutation and Implantation Failure

This study has been completed.

First Received on September 13, 2005. Last Updated on August 8, 2011 History of Changes

Sponsor:	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

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:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Infertility

U.S. FDA Resources

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

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 February 12, 2012