EARLY-PREG: Mapping maternal–embryo molecular communication before and after conception

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

EARLY-PREG is an open preconception cohort using a counterfactual design that follows healthy women from before conception through the first two weeks after fertilization, with continued follow-up into pregnancy and childbirth. Participants provide daily biosamples (saliva, urine, blood, cervicovaginal fluid and brushings) during key cycle phases; samples are processed and stored in a growing biorepository for proteomic analysis. The cohort compares menstrual cycles that result in full-term live birth, early pregnancy loss, or no pregnancy to identify molecular signatures of embryo–maternal crosstalk. The longitudinal, bidirectional approach aims to link early molecular changes to later clinical outcomes of spontaneous conception.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clínica Sanatorio Alemán
  Chiguayante, Chile Recruiting

Study contacts

• Study coordinator: Elard S Koch
• Email: ekoch@melisainstitute.org
• Phone: +56 41 246 7242

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.