Actively Recruiting
EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions
Led by MELISA Institute Genomics & Proteomics Research SpA · Updated on 2026-04-29
223
Participants Needed
1
Research Sites
542 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 18 and 40 years
- Not currently pregnant
- Normal colposcopy
- Body mass index (BMI) between 18 and 29
- Regular menstrual cycles lasting 21 to 35 days
- No chronic diseases such as hypertension, diabetes mellitus, cancer, depression, personality disorder, thyroid pathology, polycystic ovary syndrome, or hyperprolactinemia
- If seeking pregnancy, male partner aged 18 to 40 years without diabetes mellitus, depression, personality disorder, or cancer, not taking chronic medication, no erectile disorders, BMI between 18 and 29.9, moderate alcohol use, and no recreational drug use
You will not qualify if you...
- Currently pregnant women
- History of alcoholism
- Use of infertility treatment
- Endometriosis
- Pelvic inflammatory disease
- Pelvic surgery
- Allergy to latex or silicone
- If seeking pregnancy, male partners working in contact with pesticides, or with history of erectile dysfunction, mumps in adulthood, chronic diseases, or psychological problems
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clínica Sanatorio Alemán
Chiguayante, Chile
Actively Recruiting
Research Team
E
Elard S Koch
CONTACT
P
Patricio A Alcaino
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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