EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

Completed

• Conditions: Thrombophilia; Birth Rate; Embryo Implantation; Reproductive Techniques

• Registration Number: NCT02407730
• Lead Sponsor: G. d'Annunzio University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-04-03
• Primary Completion: 2017-07
• Study Completion: 2018-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 687

Inclusion Criteria

• women undergoing ART
• age 18 years or older

Exclusion Criteria

• ongoing anticoagulant therapy
• previous venous thromboembolism
• no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Live birth rate	Participants will be followed for the duration of the pregnancy, an expected average of 9 months

Secondary Outcome Measures

Name	Time	Method
implantation rate	Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks

Trial Locations

Locations (1)

Universita degli Studi G. d'Annunzio Chieti e Pescara; 🇮🇹 Chieti, Italy