Factor V Leiden Mutation and Implantation Failure - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 12, 2009

Start Date ^ICMJE

September 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00194350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Factor V Leiden Mutation and Implantation Failure

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

Retrospective

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Procedure: Test for Factor V Leiden gene mutation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

399

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00194350

Responsible Party

Kurt T Barnhart, MD, MSCE, University of Pennsylvania

Study ID Numbers ^ICMJE

704111

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kurt T Barnhart, MD, MSCE

University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP