[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620469":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":35,"responsibleParty":48,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"MELISA Institute Genomics & Proteomics Research SpA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CONCEPTION CYCLE",null,"Conception cycle refers to the menstrual cycle in which the ovum is fertilised, leading to pregnancy. Confirmation of a conception cycle requires beta-hCG levels above the clinical threshold for a positive pregnancy test, which is determined in peripheral venous blood on the 14th day post-ovulation.",[13],"Other: EMBRYO EXPOSURE",{"label":15,"type":10,"description":16,"interventionNames":10},"NON-CONCEPTION CYCLE","Non-conception cycle refers to a menstrual cycle in which pregnancy does not occur. When referring to the same individual, it is, by definition, considered the counterfactual to the conception cycle described above. Confirmation of a non-conception cycle requires a clinically negative beta-hCG test, determined in peripheral venous blood on the 14th day post-ovulation. This cycle is characterised by the absence of a clinical pregnancy.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"OTHER","EMBRYO EXPOSURE","The counterfactual design of EARLY-PREG enables the comparison of the systemic and localised physiological effects associated with embryo appearance and implantation in an individual (the factual) against the physiological state of the same individual without experiencing pregnancy (the counterfactual).",[9],[24],{"name":25,"affiliation":5,"role":26},"Elard S Koch","STUDY_DIRECTOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","+56 41 246 7242","ekoch@melisainstitute.org",{"name":33,"role":29,"phone":30,"phoneExt":10,"email":34},"Patricio A Alcaino","palcaino@melisainstitute.org",[36],{"facility":37,"status":38,"city":39,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Clínica Sanatorio Alemán","RECRUITING","Chiguayante","Chile","CL",{"type":43,"coordinates":44},"Point",[45,46],-73.02841,-36.9256,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Elard Koch, PhD","Head of research","100620469","early-preg-a-preconception-cohort-study-based-on-counterfactuals-to-study-maternal-embryonic-molecular-interactions-100620469",false,"NCT07358026","EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions","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","EARLY-PREG","Inclusion criteria:\n\n* being between 18 and 40 years of age\n* not being pregnant\n* normal colposcopy\n* body mass index (BMI) between 18 and 29\n* regular menstrual cycles (21-35 days)\n* absence of chronic diseases (hypertension, diabetes mellitus, cancer, depression, personality disorder, thyroid pathology, polycystic ovary syndrome, or hyperprolactinemia).\n* 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.\n\nExclusion criteria:\n\n* pregnant women\n* history of alcoholism\n* infertility treatment\n* endometriosis\n* pelvic inflammatory disease\n* pelvic surgery\n* allergy to latex or silicone\n* 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.",true,"FEMALE","18 Years","40 Years",{"count":65,"type":66},223,"ESTIMATED","OBSERVATIONAL","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.\n\nParticipants 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:\n\n* 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.\n* Early pregnancy loss refers to a miscarriage up to 12 6\u002F7 weeks.\n* 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.",[70,71,72,73,74],"Early Pregnancy","Early Pregnancy Loss","Childbirth","Healthy","Pregnancy",[76,77,78,79,80,81,82],"longitudinal study","counterfactual design","embryo-mother crosstalk","biorepository","maternal fluids","menstrual cycle","preconception open cohort","2026-04-24",{"date":85,"type":86},"2026-04-29","ACTUAL",{"date":88,"type":86},"2017-07-11",{"date":90,"type":66},"2027-12",{"name":5,"class":6},1]