Thrombophilia Clinical Trial
Official title:
EFFects of Thrombophilia on the Outcomes of Assisted Reproduction
NCT number | NCT02407730 |
Other study ID # | EFFORT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | May 2018 |
Verified date | August 2019 |
Source | G. d'Annunzio University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage
and pregnancy complications. Thrombophilia could favor the development of thrombosis of the
maternal vasculature and obstacle placentation. Some studies have suggested a role of
thrombophilia in the failure of assisted reproductive techniques although this association
has been recently questioned. The scope of this study is to evaluate the effect of
thrombophilia on the implantation rate and live birth rate in women undergoing ART.
Design: prospective, observational study Primary end-point: live birth rate. Secondary
end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks
post-partum
Status | Completed |
Enrollment | 687 |
Est. completion date | May 2018 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - women undergoing ART - age 18 years or older Exclusion Criteria: - ongoing anticoagulant therapy - previous venous thromboembolism - no informed consent |
Country | Name | City | State |
---|---|---|---|
Italy | Universita degli Studi G. d'Annunzio Chieti e Pescara | Chieti |
Lead Sponsor | Collaborator |
---|---|
G. d'Annunzio University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live birth rate | Participants will be followed for the duration of the pregnancy, an expected average of 9 months | ||
Secondary | implantation rate | Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks |
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