NCT06280807

Observation of Environment and Reproductive-Endocrine Effects

OBServation of Environment and ReproductiVe Endocrine Effects Study (OBSERVE Study)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: National Institute of Environmental Health Sciences (NIEHS) · NIH
• Sex: All
• Age: 8 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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. ...

Detailed description

Study Description: This study will investigate the relationship between environment, lifestyle, and reproductive function. This will include the study of these factors at enrollment and in response to clinical care for the underlying condition. This study will prospectively follow participants with endocrine reproductive disorders and collect data secondary to clinical care and data regarding internal and external environmental exposures. We hypothesize that dysregulated environment is associated with reproductive and endocrine dysfunction and the clinical phenotype may evolve in response to treatment of the dysfunction. To study the hypothesis that external and internal environmental factors are associated with reproductive and endocrine dysfunction. Objectives: * To study the hypothesis that external and internal environmental factors are associated with reproductive and endocrine dysfunction * To generate hypothesis for future studies investigating the impact of environment on human health Endpoints: Since this is an exploratory and hypothesis generating study there are no pre-defined endpoints of this study.

Conditions

• Hypogonadism
• Hypergonadism
• Precocious Puberty
• Late Puberty
• Amenorrhea

Timeline

• Start date: 2024-07-01
• Primary completion: 2039-03-28
• Completion: 2039-03-31
• First posted: 2024-02-28
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States