InfertilityNCT00194350
Factor V Leiden Mutation and Implantation Failure
An observational study of Infertility, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Test for Factor V Leiden gene mutation
- Type of treatment
- Surgery or procedure
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Infertility
- Being tested
- Test for Factor V Leiden gene mutation
- Keywords
- Infertility, Factor V Leiden
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test for Factor V Leiden gene mutationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2001
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 399 participants
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- Kurt T Barnhart, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194350
- Sponsor's protocol ID
- 704111
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Factor V Leiden Mutation in Implantation Failure
- ClinicalTrials.gov ID
- NCT00194350
- Acronym / sponsor ID
- 704111
- Conditions
- Infertility
- Keywords
- Infertility, Factor V Leiden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2001
- Study completion
- Aug 2005 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test for Factor V Leiden gene mutation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt T Barnhart, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.