Factor V Leiden Mutation and Implantation Failure

NCT ID: NCT00194350

Last Updated: 2011-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

399 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-09-30

Study Completion Date

2005-08-31

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Test for Factor V Leiden gene mutation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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University of Pennsylvania

Principal Investigators

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Kurt T Barnhart, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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704111

Identifier Type: -

Identifier Source: org_study_id

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