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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2019
Source G. d'Annunzio University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Italy Universita degli Studi G. d'Annunzio Chieti e Pescara Chieti

Sponsors (1)

Lead Sponsor Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

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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