EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

Thrombophilia Clinical Trial

Official title:

EFFects of Thrombophilia on the Outcomes of Assisted Reproduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407730
• Other study ID #: EFFORT
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Birth Rate
• Embryo Implantation
• Reproductive Techniques
• Thrombophilia

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