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Observing Environmental and Reproductive-Endocrine Effects

This observational study aims to understand how environmental factors, like pollution, diet, and sleep, might affect your body's hormone (endocrine) and reproductive systems. Researchers are looking for people aged 8 and older, assigned male or female at birth, who have conditions like hypogonadism (when your body doesn't produce enough sex hormones), infertility, or other reproductive issues. The study will collect information about your environment and lifestyle, along with your medical care for your condition, to see if there's a connection between these factors and reproductive health. This study is not testing a new treatment, but rather observing and collecting information to help future research.

Study design
This is an observational study, meaning researchers will collect information without providing any specific intervention. It plans to enroll 300 participants.
What's involved
Adult participants will have 4 to 5 visits over 5 years. Information will be collected at the start and after clinical care for your condition.
Compensation
Not stated in the trial record.
Follow-up
Information will be collected at baseline and after clinical care for the underlying condition.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06280807

Observation of Environment and Reproductive-Endocrine Effects

Recruiting
Not specifiedAges 8–99Observational
National Institute of Environmental Health Sciences (NIEHS)
~300 participants
Updated 2025-12-23 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology.
Measured over at baseline and after clinical care for the underlying condition

Conditions

Hypogonadism
Hypergonadism
Precocious Puberty
Late Puberty
Amenorrhea

Explore related trials

Androgen Excess StatesDelayed PubertyHypogonadismInfertilityPerimenopausalPolycystic Ovary SyndromePostmenopausalPrecocious PubertyReproductive Disorders

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Natalie D Shaw, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Environmental Health Sciences (NIEHS)

Who to contact

NIEHS Join A Study Recruitment Group
[email protected]
(855) 696-4347
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female hypogonadism
Obesity/metabolic syndrome related to hypogonadism.
Other reproductive dysfunction (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)
Premature Ovarian Insufficiency
Isolated hypogonadotropic hypogonadism
Polycystic Ovarian Syndrome
Delayed Puberty
Precocious puberty
Perimenopause and post-menopausal states
Androgen Excess States (Nonclassic Congenital Adrenal Hyperplasia, Extreme hyperinsulism, Idiopathic etc.)
Exhibiting signs of a diagnosis of hypogonadism, e.g., Bosma arrhinia microphthalmia syndrome (BAMS) 4. Ability of participant, legal guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

What this trial measures

  • Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology.at baseline and after clinical care for the underlying condition

    We will analyze the correlation between internal exposures, and the longitudinal evolution of endocrine disorders. For instance, changes in PSQI (sleep) and DSM-5 (mood) questionnaire scores, research analytes and hormone metrics with treatment.