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EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions

NCT07358026 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2026-04-29

No results posted yet for this study

Summary

EARLY-PREG is an open-cohort clinical study with a preconception, longitudinal, bidirectional and counterfactual design. The aim of this cohort is to investigate the proteomic signatures of maternal-embryonic communication by interrogating a growing biorepository of maternal fluids and tissues collected during the first two weeks after fertilisation.

Participants in the EARLY-PREG cohort consist of healthy couples seeking pregnancy, as well as women who are not seeking to conceive. The three main outcomes in the cohort are defined according to menstrual cycles in which conception is achieved and those in which conception is not achieved. Their clinical definitions are as follows:

* Pregnancy with a full-term live birth refers to the cycle in which the ovum is fertilised, leading to pregnancy, with beta-hCG levels above the clinical threshold for a positive pregnancy test.
* Early pregnancy loss refers to a miscarriage up to 12 6/7 weeks.
* Non-pregnancy refers to a menstrual cycle in which conception does not occur, confirmed by a clinically negative beta-hCG test. When referring to the same individual, this is, by definition, considered the counterfactual to the corresponding conception cycle.

Conditions

  • Early Pregnancy
  • Early Pregnancy Loss
  • Childbirth
  • Healthy
  • Pregnancy

Interventions

OTHER

EMBRYO EXPOSURE

The counterfactual design of EARLY-PREG enables the comparison of the systemic and localised physiological effects associated with embryo appearance and implantation in an individual (the factual) against the physiological state of the same individual without experiencing pregnancy (the counterfactual).

Sponsors & Collaborators

  • MELISA Institute Genomics & Proteomics Research SpA

    lead INDUSTRY

Principal Investigators

  • Elard S Koch · MELISA Institute Genomics & Proteomics Research SpA

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Chile

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 NCT07358026 on ClinicalTrials.gov