Observation of Environment and Reproductive-Endocrine Effects
NCT ID: NCT06280807
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-07-01
2039-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Androgen Excess States
Polycystic Ovary Syndrome (PCOS);Women who meet criteria for PCOS based on NIH/ Rotterdam or other clinical criteria
No interventions assigned to this group
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.
No interventions assigned to this group
Exhibiting signs of a diagnosis of hypogonadism
for example: Bosma arrhinia microphthalmia syndrome (BAMS)
No interventions assigned to this group
Hypogonadism / Infertility
Isolated hypogonadotropic hypogonadism
No interventions assigned to this group
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
No interventions assigned to this group
Miscellaneous
Reproductive disorders not related to the above categories. (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)
No interventions assigned to this group
Precocious or Delayed Puberty
Participants who display clinical evidence of delayed or precocious puberty based on standard criteria.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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.
8 Years
99 Years
ALL
No
Sponsors
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National Institute of Environmental Health Sciences (NIEHS)
NIH
Responsible Party
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Principal Investigators
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Natalie D Shaw, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Environmental Health Sciences (NIEHS)
Locations
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NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
NIEHS Join A Study Recruitment Group
Role: backup
References
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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.
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.
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.
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.
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.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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10001617
Identifier Type: -
Identifier Source: org_study_id
001617-E
Identifier Type: -
Identifier Source: secondary_id