Observation of Environment and Reproductive-Endocrine Effects

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-99
SponsorNational Institute of Environmental Health Sciences (NIEHS)

About this trial

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.

Reproductive Disorder Cohorts:

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.

Menopausal Women Cohort:

Eligibility:

Inclusion criteria:

Females, ages 40-62, in late perimenopause (skipped at least 2 menstrual periods) or early post menopause (last menstrual period within 2 years), with a history of regular menstrual cycles during reproductive years.

Exclusion Criteria:

Previous surgery or procedure that induces amenorrhea or menopause, diagnosis of reproductive disorder, symptoms of irregular menstrual cycles, or medication or device use (eg, birth control pills) that would prevent the determination of menopausal status.

Design:

Women will have one study visit, and three at home specimen collections: Study visit, At home collections Day 7, Month 2 and Month 4.

At the study visit, women will be screened, complete questionnaires, provide blood and urine for lab testing for hormones and chemical exposures, and a Body composition measure.

Women will collect first morning void before their study visit, Month 2 and Month 4. A wristband (for chemical exposures) is worn from the study visit for 7 Days.

Women will complete questionnaires during at home collections at Day 7, Month 2 and Month 4....

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Male or female hypogonadism

Disqualifiers

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.

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.

Female, referring to sex assigned at birth (cis gender)

Trial population

Adult cisgender females, from the communities and surrounding areas of Durham, Chapel Hill and Raleigh in NC. - Currently Recruiting. Adult cisgender males 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 - NOT currently recruiting. Recruitment may resume in the future. Not recruiting in Bethesda, Maryland. Recruitment may resume in the future.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 11 trial groups

11

Trial groups

See each trial group below.

Group A: Androgen Excess States- NOT Currently Recruiting[Recruitment may resume in the future.]
Group B: Congenital Adrenal Hyperplasia - Currently Recruiting
Group C: Exhibiting signs of a diagnosis of hypogonadism- NOT Currently Recruiting
Group D: Hyperandrogenism- NOT Currently Recruiting[Recruitment may resume in the future.]
Group E: Hypogonadism / Infertility - NOT Currently Recruiting [Recruitment may resume in the future.]
Group F: Hypothalamic Amenorrhea (female) Functional Hypogonadism (male) - NOT Currently Recruiting
Group G: Miscellaneous - NOT Currently Recruiting[Recruitment may resume in the future.]
Group H: Perimenopause Menopause- Currently Recruiting[Recruitment may resume in the future.]
Group I: Precocious or Delayed Puberty - NOT Currently Recruiting[Recruitment may resume in the future.]
Group J: Premature Ovarian Insufficiency - NOT Currently Recruiting [Recruitment may resume in the future.]
Group K: Weight *Overweight/Underweight - NOT Currently Recruiting [Recruitment may resume in the future.]

Trial outcomes

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.

Time frame
at baseline and after clinical care for the underlying condition

Secondary outcomes

1

the influence of behavioral and psychological factors on reproductive function

We will analyze the correlation between external exposures, and the longitudinal evolution of endocrine disorders. For instance, we will assess for changes in (stress), eating disorders and exposome information (derived from co-enrollment in the PEGS study) before and after treatment.

Time frame
at baseline and after clinical care for the underlying condition
2

the impact of stress on reproductive dysfunction

We will analyze the correlation between external exposures, and the longitudinal evolution of endocrine disorders. For instance, we will assess for changes in (stress), eating disorders and exposome information (derived from co-enrollment in the PEGS study) before and after treatment.

Time frame
at baseline and after clinical care for the underlying condition
3

the relationship between nutrition, diet and reproduction

We will analyze the correlation between external exposures, and the longitudinal evolution of endocrine disorders. For instance, we will assess for changes in (stress), eating disorders and exposome information (derived from co-enrollment in the PEGS study) before and after treatment.

Time frame
at baseline and after clinical care for the underlying condition
4

Greater exposure to EDCs will be associated with increased hot flash frequency in perimenopausal and menopausal women.

We will analyze the correlation between Endocrine Disrupting Chemicals in urine, blood, and wristband, exposome information (derived from co-enrollment in the PEGS study) and hot flash frequency.

Time frame
at baseline, month 2 and month 4

Other outcomes

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