Observation of Environment and Reproductive-Endocrine Effects

NCT06280807 | Recruiting

• 2 other identifiers: 10001617001617-E
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Hypogonadism; Hypergonadism; Precocious Puberty; Late Puberty; Amenorrhea

Keywords

Endocrine; Reproductive Disorders; Hypothalamic-Pituitary-Gonadal Endocrine Axis

Outcome Measures

Primary Outcomes (1)

• Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology.

  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.

  at baseline and after clinical care for the underlying condition

Secondary Outcomes (3)

• the relationship between nutrition, diet and reproduction

  at baseline and after clinical care for the underlying condition

• the impact of stress on reproductive dysfunction

  at baseline and after clinical care for the underlying condition

• the influence of behavioral and psychological factors on reproductive function

  at baseline and after clinical care for the underlying condition

Study Arms (9)

Androgen Excess States

Polycystic Ovary Syndrome (PCOS);Women who meet criteria for PCOS based on NIH/ Rotterdam or other clinical criteria

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.

Exhibiting signs of a diagnosis of hypogonadism

for example: Bosma arrhinia microphthalmia syndrome (BAMS)

Hypogonadism / Infertility

Isolated hypogonadotropic hypogonadism

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

Miscellaneous

Reproductive disorders not related to the above categories. (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)

Precocious or Delayed Puberty

Participants who display clinical evidence of delayed or precocious puberty based on standard criteria.

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.

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.

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric (between the ages of 8 and 18), cisgender male and females, from the communities and surrounding areas of Durham, Chapel Hill and Raleigh in NC; and Bethesda, MD.

You may qualify if:

• 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 (cis gender)
• Age \> 8 years and weight \>= 12 kg
• 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.)

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Publications (5)

• Moran LJ, Hutchison SK, Norman RJ, Teede HJ. Lifestyle changes in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD007506. doi: 10.1002/14651858.CD007506.pub3.

  PMID: 21735412 BACKGROUND

• Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors and reproductive health: taking control of your fertility. Reprod Biol Endocrinol. 2013 Jul 16;11:66. doi: 10.1186/1477-7827-11-66.

  PMID: 23870423 BACKGROUND

• Roychoudhury S, Chakraborty S, Choudhury AP, Das A, Jha NK, Slama P, Nath M, Massanyi P, Ruokolainen J, Kesari KK. Environmental Factors-Induced Oxidative Stress: Hormonal and Molecular Pathway Disruptions in Hypogonadism and Erectile Dysfunction. Antioxidants (Basel). 2021 May 24;10(6):837. doi: 10.3390/antiox10060837.

  PMID: 34073826 BACKGROUND

• Corona G, Rastrelli G, Morelli A, Sarchielli E, Cipriani S, Vignozzi L, Maggi M. Treatment of Functional Hypogonadism Besides Pharmacological Substitution. World J Mens Health. 2020 Jul;38(3):256-270. doi: 10.5534/wjmh.190061. Epub 2019 Aug 29.

  PMID: 31496147 BACKGROUND

• Gravholt CH, Chang S, Wallentin M, Fedder J, Moore P, Skakkebaek A. Klinefelter Syndrome: Integrating Genetics, Neuropsychology, and Endocrinology. Endocr Rev. 2018 Aug 1;39(4):389-423. doi: 10.1210/er.2017-00212.

  PMID: 29438472 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hypogonadism; Puberty, Precocious; Amenorrhea

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalie D Shaw, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIEHS Join A Study Recruitment Group

CONTACT

(855) 696-4347; myniehs@nih.gov

Natalie D Shaw, M.D.

CONTACT

(984) 287-3716; natalie.shaw@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: February 28, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): March 28, 2039
• Study Completion (Estimated): March 31, 2039
• Last Updated: December 23, 2025

Record last verified: 2025-12-19

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available with the scientific publication upon reasonable request. In some cases, especially per journal policy and as appropriate, we will deposit deidentified data.
• Access Criteria: Aggregated summary and statistical analysis will be publicly available. All the patient-level data will require controlled access.

Locations

US (1)