- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00194350
Factor V Leiden Mutation and Implantation Failure
August 8, 2011 updated by: University of Pennsylvania
Evaluation of the Role of Factor V Leiden Mutation in Implantation Failure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment
399
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Reproductive Research Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
August 9, 2011
Last Update Submitted That Met QC Criteria
August 8, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 704111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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