Observation of Environment and Reproductive-Endocrine Effects | National Institute of Environmental Health Sciences

Observation of Environment and Reproductive-Endocrine Effects | National Institute of Environmental Health Sciences
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Study Background
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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.
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Male or female, referring to sex assigned at birth.
Age > 8 years and weight >= 12 kg.
A diagnosis of hypogonadism, infertility or other reproductive dysfunction.
Ability of participant, legal guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Some specific diagnoses (as defined in standard guidelines) will include:
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.)
Or
Exhibiting signs of a diagnosis of hypogonadism, e.g., Bosma arrhinia microphthalmia syndrome (BAMS)
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
A diagnosis of a serious medical disorder such as malignancy or heart disease will be grounds for exclusion at the discretion of the PI or AI.
Inability to follow up with the research study and/or perform study procedures, at the discretion of the PI or AI.
Pregnant participants, less than 18 years of age, for their safety, since there is not a trained doctor on the study to give proper medical care to pregnant individuals less than 18 years of age.
Individuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.
Principal Investigator
Natalie D. Shaw, M.D., MMSc.
Senior Investigator
Tel 984-287-3716
[email protected]
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Last Reviewed: December 30, 2025