Observation of Environment and Reproductive-Endocrine Effects

Part of paid clinical trials in Research Triangle Park, North Carolina.

Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Study ID
NCT06280807
Status
Recruiting
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Conditions

  • Amenorrhea
  • Hypergonadism
  • Hypogonadism
  • Late Puberty
  • Precocious Puberty

Eligibility Criteria

Sex
ALL
Age
8 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

Background: Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems. Objective: To learn how environmental factors may affect the endocrine and reproductive systems. Eligibility: Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders. Design: Adult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours. Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis. Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include: Body composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume. Resting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest. ...

Key Dates

Start date
Jul 1, 2024
Status verified
Dec 2025
Primary completion
Mar 28, 2039
Completion
Mar 31, 2039

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Androgen Excess States
    Polycystic Ovary Syndrome (PCOS);Women who meet criteria for PCOS based on NIH/ Rotterdam or other clinical criteria
  • Arm: Congenital Adrenal Hyperplasia / Hyperandrogenism
    Women who exhibit evidence of hyperandrogenism not related to Polycystic Ovarian Syndrome (PCOS); Nonclassic Congenital Adrenal Hyperplasia, Extreme hyperinsulism, Idiopathic etc.
  • Arm: Exhibiting signs of a diagnosis of hypogonadism
    for example: Bosma arrhinia microphthalmia syndrome (BAMS)
  • Arm: Hypogonadism / Infertility
    Isolated hypogonadotropic hypogonadism
  • Arm: Hypothalamic Amenorrhea (HA) (female) Functional Hypogonadism (male)
    Participants who experience secondary or primary amenorrhea, or male hypogonadism, in the setting of negative energy balance such dieting, eating disorders or exercise training
  • Arm: Miscellaneous
    Reproductive disorders not related to the above categories. (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)
  • Arm: Precocious or Delayed Puberty
    Participants who display clinical evidence of delayed or precocious puberty based on standard criteria.
  • Arm: Premature Ovarian InsufficiencyPerimenopause or post-menopausal states
    Women who attain menopause before age 40 years (or as defined by clinical criteria). Perimenopausal women are those typically above age 40 years and experience secondary amenorrhea/ oligomenorrhea.
  • Arm: Weight *Overweight/Underweight
    BMI below or above reference standard (Adult Reference: Asians/ Asian Americans- 18.5-22.9 kg/m2; Other races- 18.5-24.9 kg/m2\*Participants may simultaneously belong to cohort of weight and any other cohort.

Primary Outcome Measure

Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology. [ Time Frame: at baseline and after clinical care for the underlying condition ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NIEHS Clinical Research Unit (CRU)Research Triangle ParkNorth Carolina27709
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222
NIEHS Join A Study Recruitment Group
[email protected]
(855) 696-4347

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NIEHS Clinical Research Unit (CRU)· Research Triangle Park, NC

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