Observing how the environment affects reproductive health

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

This study looks at how different environmental factors might affect reproductive health in people aged 8 and older, including issues like infertility and hormone problems.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 8 Years to 99 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Research Triangle Park, North Carolina)
• Trial ID: NCT06280807 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between environmental factors and reproductive endocrine disorders such as hypogonadism and infertility. Participants aged 8 years and older will undergo multiple visits over a period of up to 5 years, during which they will receive physical exams, blood and urine tests, and complete questionnaires. The study will collect data on both internal and external environmental exposures to understand their impact on reproductive health. The goal is to generate hypotheses for future research on how environmental influences affect endocrine function.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 8 years and older with diagnoses of hypogonadism, infertility, or other reproductive disorders.

Not a fit: Patients without reproductive endocrine disorders or those under 8 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how environmental factors contribute to reproductive health issues, potentially leading to improved prevention and treatment strategies.

How similar studies have performed: While the specific approach of this study is exploratory, similar studies have shown that environmental factors can significantly impact endocrine and reproductive health.

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.

Where this trial is running

Research Triangle Park, North Carolina

• NIEHS Clinical Research Unit (CRU) — Research Triangle Park, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Natalie D Shaw, M.D. — National Institute of Environmental Health Sciences (NIEHS)
• Study coordinator: NIEHS Join A Study Recruitment Group

Conditions: Hypogonadism, Hypergonadism, Precocious Puberty, Late Puberty, Amenorrhea, Endocrine, Reproductive Disorders, Hypothalamic-Pituitary-Gonadal Endocrine Axis