EARLY-PREG: Mapping maternal–embryo molecular communication before and after conception
EARLY-PREG: A Preconception, Longitudinal, Bidirectional, and Counterfactual Cohort Study of Women Seeking Pregnancy, Designed to Investigate Maternal-Embryonic Molecular Interactions During the Peri-implantation Window
This project will test whether patterns of proteins and other molecules in maternal fluids change in the first two weeks after fertilization in healthy women trying to conceive and in women not seeking pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 223 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | MELISA Institute Genomics & Proteomics Research SpA Industry-sponsored |
| Locations | 1 site (Chiguayante) |
| Trial ID | NCT07358026 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Healthy women aged 18–40 with regular menstrual cycles and BMI 18–29 who are not currently pregnant, including those trying to conceive with a healthy male partner or women not seeking pregnancy, are ideal candidates.
Not a fit: People with chronic diseases, known fertility disorders, prior pelvic disease or surgery, allergy to study materials, or those undergoing infertility treatments are unlikely to benefit from or be eligible for this cohort focused on spontaneous conception.
Why it matters
Potential benefit: If successful, this work could identify early molecular markers that predict whether a conception will progress to full-term pregnancy or result in early loss, enabling earlier counseling and focused research on interventions.
How similar studies have performed: Animal and in vitro work supports embryo–maternal signaling and small human proteomic studies suggest informative markers, but a preconception, counterfactual in vivo human cohort like EARLY-PREG is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chiguayante
- Clínica Sanatorio Alemán — Chiguayante, Chile (Recruiting)
Study contacts
- Study coordinator: Elard S Koch
- Email: ekoch@melisainstitute.org
- Phone: +56 41 246 7242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.