Actively Recruiting
Observation of Environment and Reproductive-Endocrine Effects
Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2025-12-23
300
Participants Needed
1
Research Sites
769 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. ...
CONDITIONS
Official Title
Observation of Environment and Reproductive-Endocrine Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, referring to sex assigned at birth (cis gender)
- Age over 8 years and weight at least 12 kg
- Diagnosis of hypogonadism, infertility, or other reproductive dysfunction
- Specific diagnoses include male or female hypogonadism, obesity/metabolic syndrome related to hypogonadism, other reproductive dysfunctions related to endocrine issues, thyroid disorders, Cushing syndrome, pharmacotherapy, premature ovarian insufficiency, isolated hypogonadotropic hypogonadism, polycystic ovarian syndrome, delayed puberty, precocious puberty, perimenopause and post-menopausal states, androgen excess states (e.g., nonclassic congenital adrenal hyperplasia, extreme hyperinsulism, idiopathic)
- Exhibiting signs of hypogonadism such as Bosma arrhinia microphthalmia syndrome (BAMS)
- Ability of participant or legal guardian to understand and sign informed consent
You will not qualify if you...
- Diagnosis of a serious medical disorder such as malignancy or heart disease, as determined by the study doctor
- Inability to follow up with the study or perform study procedures, as determined by the study doctor
- Pregnant participants under 18 years of age, due to safety concerns and lack of trained medical care for this group in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States, 27709
Actively Recruiting
Research Team
N
NIEHS Join A Study Recruitment Group
CONTACT
N
Natalie D Shaw, M.D.
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
9
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