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Early Pregnancy Cohort and Preimplantation Factor

NCT02761772 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2019-03-27

No results posted yet for this study

Summary

Miscarriage is a common event associated with severe psychological and social morbidity, further tormenting in women suffering recurrent pregnancy loss (RPL) by at least three consecutive losses.

Ultrasonography and biomarkers have yet to precisely predict viability in pregnancies with symptoms of threatening miscarriage.

A novel biomarker Preimplantation Factor (PIF) derived by the developing embryo might be the key factor for this prediction ameliorating the implantation process by promoting a favorable local immune system in the uterus.

The investigators aim to establish a prospective early pregnancy cohort (PEP-cohort) that includes women throughout the first trimester by both assisted reproductive technology (ART) and spontaneous conceptions. By a combination of consecutive ultrasonographys and blood samples of known predictors of implantation PIF as a predictor of viability will be evaluated.

These data are finally compared to the same data in a retrospective cohort of RPL patients emphasizing the role of PIF.

All collected data will be stored in a Research Biobank for the current studies outlined as well as potential future studies of reproductive medicine in the first trimester.

Conditions

  • Luteal Phase
  • Biomarkers
  • Abortion, Spontaneous
  • Abortion, Habitual
  • Pregnancy

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • BioIncept LLC

    collaborator INDUSTRY

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Jesper F Petersen, M. D. · Nordsjaellands Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-09-30
Completion
2018-12-31

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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 NCT02761772 on ClinicalTrials.gov