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EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

Sponsor
G. d'Annunzio University (Other)
Overall Status
Completed
CT.gov ID
NCT02407730
Collaborator
(none)
687
Enrollment
1
Location
40
Duration (Months)
17.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    687 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    EFFects of Thrombophilia on the Outcomes of Assisted Reproduction
    Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2017
    Actual Study Completion Date :
    May 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Live birth rate [Participants will be followed for the duration of the pregnancy, an expected average of 9 months]

    Secondary Outcome Measures

    1. implantation rate [Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • women undergoing ART

    • age 18 years or older

    Exclusion Criteria:

    • ongoing anticoagulant therapy

    • previous venous thromboembolism

    • no informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universita degli Studi G. d'Annunzio Chieti e Pescara Chieti Italy 66100

    Sponsors and Collaborators

    • G. d'Annunzio University

    Investigators

    • Principal Investigator: Marcello Di Nisio, University G. D'Annunzio, Chieti, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marcello Di Nisio, Principal Investigator, G. d'Annunzio University
    ClinicalTrials.gov Identifier:
    NCT02407730
    Other Study ID Numbers:
    • EFFORT
    First Posted:
    Apr 3, 2015
    Last Update Posted:
    Aug 8, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Thrombophilia

    Study Results

    No Results Posted as of Aug 8, 2019