Observation of Environment and Reproductive-Endocrine Effects

Launched by NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) · Feb 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different environmental factors, like pollution and chemicals, might affect hormone levels and reproductive health in people. Hormone problems can lead to issues such as early or late puberty, irregular periods, or infertility. The researchers want to understand these effects better to help improve treatments for conditions like hypogonadism (low hormone levels), hypergonadism (high hormone levels), and other reproductive disorders.

To participate in this study, individuals aged 8 and older, who have certain hormone-related conditions, may be eligible. Participants will visit the research center several times over a few years, where they will undergo various tests, including physical exams and blood and urine tests. For children, the study can continue until they are 23 years old. Most visits will take less than three hours. The study aims to gather important information about how our surroundings might be influencing our hormone health, which could lead to better care in the future.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• • 1. Male or female, referring to sex assigned at birth (cis gender)
• • 2. Age \> 8 years and weight \>= 12 kg
• • 3. A diagnosis of hypogonadism, infertility or other reproductive dysfunction
• 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)
• • 4. Ability of participant, legal guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
• EXCLUSION CRITERIA:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. 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.
• • 2. Inability to follow up with the research study and/or perform study procedures, at the discretion of the PI or AI.
• • 3. 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.