NCT00194350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

First QC Date

September 13, 2005

Last Update Submit

August 8, 2011

Conditions

Infertility

Keywords

InfertilityFactor V Leiden

Interventions

Test for Factor V Leiden gene mutationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Kurt T Barnhart, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

September 1, 2001

Study Completion

August 1, 2005

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations

US(1)