EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

EFFects of Thrombophilia on the Outcomes of Assisted Reproduction

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 687

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • Universita degli Studi G. d'Annunzio Chieti e Pescara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All women 18 years or older undergoing ART

Description

Inclusion Criteria:

• women undergoing ART
• age 18 years or older

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Live birth rate	Participants will be followed for the duration of the pregnancy, an expected average of 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: March 20, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Thrombophilia
• Other Study ID Numbers: EFFORT