protocolSection identificationModule nctId: NCT06280807, orgStudyIdInfo id: 10001617, secondaryIdInfos id: 001617-E, briefTitle: Observation of Environment and Reproductive-Endocrine Effects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2039-03-28, completionDateStruct date: 2039-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Environmental Health Sciences (NIEHS), class: NIH, descriptionModule briefSummary: Background:Endocrine 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.Objective:To learn how environmental factors may affect the endocrine and reproductive systems.Eligibility:Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders.Design:Adult 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.Participants 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.Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include:Body 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.Resting 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...., conditionsModule conditions: Hypogonadism, conditions: Hypergonadism, conditions: Precocious Puberty, conditions: Late Puberty, conditions: Amenorrhea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology., secondaryOutcomes measure: the relationship between nutrition, diet and reproduction, secondaryOutcomes measure: the impact of stress on reproductive dysfunction, secondaryOutcomes measure: the influence of behavioral and psychological factors on reproductive function, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NIEHS Clinical Research Unit (CRU), status: RECRUITING, city: Research Triangle Park, state: North Carolina, zip: 27709, country: United States, contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: 800-411-1222, phoneExt: TTY dial 711, email: ccopr@nih.gov, contacts name: NIEHS Join A Study Recruitment Group, role: CONTACT, phone: (855) 696-4347, email: myniehs@nih.gov, geoPoint lat: 35.90567, lon: -78.90497, hasResults: False