[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537667":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":72,"collaborators":10,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,12,15,18,21,24,27,30,33],{"label":9,"type":10,"description":11,"interventionNames":10},"Androgen Excess States",null,"Polycystic Ovary Syndrome (PCOS);Women who meet criteria for PCOS based on NIH\u002F Rotterdam or other clinical criteria",{"label":13,"type":10,"description":14,"interventionNames":10},"Congenital Adrenal Hyperplasia \u002F Hyperandrogenism","Women who exhibit evidence of hyperandrogenism not related to Polycystic Ovarian Syndrome (PCOS); Nonclassic Congenital Adrenal Hyperplasia, Extreme hyperinsulism, Idiopathic etc.",{"label":16,"type":10,"description":17,"interventionNames":10},"Exhibiting signs of a diagnosis of hypogonadism","for example: Bosma arrhinia microphthalmia syndrome (BAMS)",{"label":19,"type":10,"description":20,"interventionNames":10},"Hypogonadism \u002F Infertility","Isolated hypogonadotropic hypogonadism",{"label":22,"type":10,"description":23,"interventionNames":10},"Hypothalamic Amenorrhea (HA) (female) Functional Hypogonadism (male)","Participants who experience secondary or primary amenorrhea, or male hypogonadism, in the setting of negative energy balance such dieting, eating disorders or exercise training",{"label":25,"type":10,"description":26,"interventionNames":10},"Miscellaneous","Reproductive disorders not related to the above categories. (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)",{"label":28,"type":10,"description":29,"interventionNames":10},"Precocious or Delayed Puberty","Participants who display clinical evidence of delayed or precocious puberty based on standard criteria.",{"label":31,"type":10,"description":32,"interventionNames":10},"Premature Ovarian InsufficiencyPerimenopause or post-menopausal states","Women who attain menopause before age 40 years (or as defined by clinical criteria). Perimenopausal women are those typically above age 40 years and experience secondary amenorrhea\u002F oligomenorrhea.",{"label":34,"type":10,"description":35,"interventionNames":10},"Weight *Overweight\u002FUnderweight","BMI below or above reference standard (Adult Reference: Asians\u002F Asian Americans- 18.5-22.9 kg\u002Fm2; Other races- 18.5-24.9 kg\u002Fm2\\*Participants may simultaneously belong to cohort of weight and any other cohort.",[37],{"name":38,"affiliation":39,"role":40},"Natalie D Shaw, M.D.","National Institute of Environmental Health Sciences (NIEHS)","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"NIEHS Join A Study Recruitment Group","CONTACT","(855) 696-4347","myniehs@nih.gov",{"name":38,"role":44,"phone":48,"phoneExt":10,"email":49},"(984) 287-3716","natalie.shaw@nih.gov",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"NIEHS Clinical Research Unit (CRU)","RECRUITING","Research Triangle Park","North Carolina","27709","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-78.86029,35.89709,{"lat":63,"lon":62},[66,71],{"name":67,"role":44,"phone":68,"phoneExt":69,"email":70},"NIH Clinical Center Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},{"type":73,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100537667","observation-of-environment-and-reproductive-endocrine-effects-100537667",false,"NCT06280807","Observation of Environment and Reproductive-Endocrine Effects","OBServation of Environment and ReproductiVe Endocrine Effects Study (OBSERVE Study)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, referring to sex assigned at birth (cis gender)\n2. Age \\> 8 years and weight \\>= 12 kg\n3. A diagnosis of hypogonadism, infertility or other reproductive dysfunction\n\n   Some specific diagnoses (as defined in standard guidelines) will include:\n   * Male or female hypogonadism\n\n     * Obesity\u002Fmetabolic syndrome related to hypogonadism.\n     * Other reproductive dysfunction (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)\n     * Premature Ovarian Insufficiency\n     * Isolated hypogonadotropic hypogonadism\n   * Polycystic Ovarian Syndrome\n   * Delayed Puberty\n   * Precocious puberty\n   * Perimenopause and post-menopausal states\n   * Androgen Excess States (Nonclassic Congenital Adrenal Hyperplasia, Extreme hyperinsulism, Idiopathic etc.)\n\n   or\n\n   -Exhibiting signs of a diagnosis of hypogonadism, e.g., Bosma arrhinia microphthalmia syndrome (BAMS)\n4. Ability of participant, legal guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. A diagnosis of a serious medical disorder such as malignancy or heart disease will be grounds for exclusion at the discretion of the PI or AI.\n2. Inability to follow up with the research study and\u002For perform study procedures, at the discretion of the PI or AI.\n3. Pregnant participants, less than 18 years of age, for their safety, since there is not a trained doctor on the study to give proper medical care to pregnant individuals less than 18 years of age.\n\nIndividuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.","ALL","8 Years","99 Years",{"count":85,"type":86},300,"ESTIMATED","OBSERVATIONAL","Background:\n\nEndocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems.\n\nObjective:\n\nTo learn how environmental factors may affect the endocrine and reproductive systems.\n\nEligibility:\n\nMales or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders.\n\nDesign:\n\nAdult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours.\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis.\n\nSpecific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include:\n\nBody composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume.\n\nResting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest.\n\n...",[90,91,92,93,94],"Hypogonadism","Hypergonadism","Precocious Puberty","Late Puberty","Amenorrhea",[96,97,98],"Endocrine","Reproductive Disorders","Hypothalamic-Pituitary-Gonadal Endocrine Axis","2025-12-20",{"date":101,"type":102},"2025-12-23","ACTUAL",{"date":104,"type":102},"2024-07-01",{"date":106,"type":86},"2039-03-31",{"name":39,"class":6},1]