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

Recruitingn/aAges 18 Years - 40 YearsFemaleMELISA Institute Genomics & Proteomics Research S…
NCT07358026 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pregn

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📋 Eligibility rules (as published)
Inclusion criteria: * being between 18 and 40 years of age * not being pregnant * normal colposcopy * body mass index (BMI) between 18 and 29 * regular menstrual cycles (21-35 days) * absence of chronic diseases (hypertension, diabetes mellitus, cancer, depression, personality disorder, thyroid pathology, polycystic ovary syndrome, or hyperprolactinemia). * If seeking pregnancy, they were included if their partners were males between 18 and 40 years old, without pathologies (diabetes mellitus, depression, personality disorder, or cancer), were not taking chronic medication, without erectile disorders, BMI between 18 and 29.9, moderate alcohol use, and with no recreational drug use. Exclusion criteria: * pregnant women * history of alcoholism * infertility treatment * endometriosis * pelvic inflammatory disease * pelvic surgery * allergy to latex or silicone * If seeking pregnancy, they were excluded if their partners were working in contact with pesticides, or with history of erectile dysfunction, or history of mumps in adulthood, or with chronic diseases, or with psychological problems.
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What it tests

  • EMBRYO EXPOSURE
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Where

1 site
Clínica Sanatorio Alemán
Chiguayante, Chile
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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