NCT07358026 EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions
| NCT ID | NCT07358026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MELISA Institute Genomics & Proteomics Research SpA |
| Condition | Early Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 223 participants |
| Start Date | 2017-07-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 223 participants in total. It began in 2017-07-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Elard S Koch
STUDY DIRECTOR
MELISA Institute Genomics & Proteomics Research SpA
Frequently Asked Questions
Who can join the NCT07358026 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Early Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07358026 currently recruiting?
Yes, NCT07358026 is actively recruiting participants. Contact the research team at ekoch@melisainstitute.org for enrollment information.
Where is the NCT07358026 trial being conducted?
This trial is being conducted at Chiguayante, Chile.
Who is sponsoring the NCT07358026 clinical trial?
NCT07358026 is sponsored by MELISA Institute Genomics & Proteomics Research SpA. The principal investigator is Elard S Koch at MELISA Institute Genomics & Proteomics Research SpA. The trial plans to enroll 223 participants.