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EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

NCT ID: NCT02407730

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

687 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Birth Rate Embryo Implantation Reproductive Techniques Thrombophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* women undergoing ART
* age 18 years or older

Exclusion Criteria

* ongoing anticoagulant therapy
* previous venous thromboembolism
* no informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Marcello Di Nisio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcello Di Nisio

Role: PRINCIPAL_INVESTIGATOR

University G. D'Annunzio, Chieti, Italy

Locations

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Universita degli Studi G. d'Annunzio Chieti e Pescara

Chieti, , Italy

Site Status

Countries

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Italy

Other Identifiers

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EFFORT

Identifier Type: -

Identifier Source: org_study_id

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