Actively Recruiting

Age: 8Years - 99Years
All Genders
ID06280807

Observation of Environment and Reproductive Endocrine Effects Study (OBSERVE Study)

Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2025-12-23

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how environmental factors like pollution, chemical exposure, foods, medicines, and sleep habits may affect the endocrine and reproductive systems. The study focuses on individuals with hormone-related conditions such as hypogonadism, infertility, and other reproductive disorders. It aims to explore the possible links between internal and external environmental exposures and reproductive and endocrine dysfunction over time. Participants include males and females aged 8 years and older with various reproductive endocrine disorders, including polycystic ovary syndrome, hypogonadism, delayed or precocious puberty, and other related conditions. Children may participate until age 23, with up to 12 visits over five years, while adults may have 4 to 5 visits during the same period. During visits, participants undergo physical exams, blood and urine tests, questionnaires about diet and health, and sometimes additional tests like imaging scans or semen analysis. Throughout the study, researchers will collect data on body composition, resting energy expenditure, nutrition, stress, and psychological factors related to reproductive health. Most visits last less than three hours. The main goal is to assess how environment and lifestyle relate to reproductive neuroendocrinology at baseline and after clinical care. The study includes ongoing monitoring and data collection to better understand reproductive and endocrine health over time.

CONDITIONS

Brief Title

Observation of Environment and Reproductive-Endocrine Effects

Who Can Participate

Age: 8Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, referring to sex assigned at birth
  • Age greater than 8 years and weight at least 12 kilograms
  • Diagnosis of hypogonadism, infertility, or other reproductive dysfunction such as polycystic ovary syndrome, delayed or precocious puberty, premature ovarian insufficiency, isolated hypogonadotropic hypogonadism, androgen excess states, or perimenopause/post-menopause
  • Ability to understand and willingness to sign written informed consent or have a legal guardian able to consent
Not Eligible

You will not qualify if you...

  • Diagnosis of a serious medical disorder such as cancer or heart disease, as determined by the study doctor
  • Inability to follow up with the study or complete study procedures, as determined by the study doctor
  • Pregnant participants under 18 years old, for safety reasons due to lack of trained medical care in the study
  • Acute, reversible, or transient medical conditions that may temporarily prevent participation until stabilized

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to approximately 18 years

Participants are observed over time to study the relationship between environment, lifestyle, and reproductive endocrine function.

Assessments at baseline and after clinical care for the underlying condition

Trial Site Locations

Total: 1 location

1

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States, 27709

Actively Recruiting

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Research Team

N

NIEHS Join A Study Recruitment Group

N

Natalie D Shaw, M.D.

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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Published Research Related To This Trial

Environmental Factors-Induced Oxidative Stress: Hormonal and Molecular Pathway Disruptions in Hypogonadism and Erectile Dysfunction.

Shubhadeep Roychoudhury, Saptaparna Chakraborty, Arun Paul Choudhury...

https://pubmed.ncbi.nlm.nih.gov/34073826