NCT02407730

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
687

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

2.5 years

First QC Date

March 20, 2015

Last Update Submit

August 7, 2019

Conditions

Birth RateEmbryo ImplantationReproductive TechniquesThrombophilia

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    Participants will be followed for the duration of the pregnancy, an expected average of 9 months

Secondary Outcomes (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

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women 18 years or older undergoing ART

You may qualify if:

  • women undergoing ART
  • age 18 years or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universita degli Studi G. d'Annunzio Chieti e Pescara

Chieti, 66100, Italy

Location

MeSH Terms

Conditions

Thrombophilia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Marcello Di Nisio

    University G. D'Annunzio, Chieti, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2015

First Posted

April 3, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Study Completion

May 1, 2018

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations

IT(1)