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Prediction of Recurrent Pregnancy Loss by a New Thrombophilia Based Genetic Risk Score

NCT03336463 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 364

Last updated 2017-11-08

No results posted yet for this study

Summary

Recurrent pregnancy loss (RPL) is a clinical problem affecting 1-5% of couples of reproductive age. The contribution of thrombophilia to RPL is disputed. This controversy is partly due to low sensitivity of the genetic variants currently used to evaluate hereditary thrombophilia: the Leiden mutation (identified as rs6025) in the coagulation factor 5 (F5L) gene and mutation G20210A (identified as rs1799963) in the prothrombin (PT) gene.

Our objective was to determine whether a wider algorithm that includes clinic and genetic variants associated with thrombophilia could be more useful in the prediction for RPL than FVL and PT alone.

Conditions

  • Miscarriage, Recurrent

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    collaborator OTHER

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

    collaborator OTHER

  • IVI-RMA London

    collaborator UNKNOWN

  • Instituto de Investigacion Sanitaria La Fe

    collaborator OTHER

  • Gendiag.exe, S.L.

    collaborator UNKNOWN

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER

  • Ferrer inCode, S.L.

    lead INDUSTRY

Principal Investigators

  • Eduardo S Salas, MD, PhD · Ferrer inCode, S.L.

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-11-30
Completion
2017-01-31

Countries

  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336463 on ClinicalTrials.gov