Factor V Leiden Mutation and Implantation Failure - Tabular View

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Factor V Leiden Mutation and Implantation Failure

This study has been completed.

Study NCT00194350. Last updated on July 26, 2008. Information provided by University of Pennsylvania

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Factor V Leiden Mutation and Implantation Failure

Official Title ^†

Evaluation of the Role of Factor V Leiden Mutation in Implantation Failure

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Retrospective

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Infertility

Intervention ^†

Procedure: Test for Factor V Leiden gene mutation

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

399

Start Date ^†

September 2001

Completion Date

August 2005

Eligibility 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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00194350

Organization ID

704111

Secondary IDs ^††

Study Sponsor ^†

University of Pennsylvania

Collaborators ^††

Investigators ^†

Principal Investigator:

Kurt T Barnhart, MD, MSCE

University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

July 2008

First Received Date ^†

September 13, 2005

Last Updated Date

July 26, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.