Clinical trial Recruiting at 1 site Observational Ages 8 to 99

Observing how the environment affects reproductive health

Official title: OBServation of Environment and ReproductiVe Endocrine Effects Study (OBSERVE Study)

Run by National Institutes of Health Clinical Center (CC) · NCT06280807 · Data updated 2026-11-12

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 typeObservational
Ages8 Years to 99 Years
SexAll
Enrollment300 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Drugs / interventionschemotherapy, radiation
Locations1 site (Research Triangle Park, North Carolina)
StatusRecruiting
StartedJuly 1, 2024
Main results expectedMarch 28, 2039
Study endsMarch 31, 2039
Registry record updatedSeptember 28, 2026
Trial IDNCT06280807 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:

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.)

or

--Exhibiting signs of a diagnosis of hypogonadism, e.g., Bosma arrhinia microphthalmia syndrome (BAMS)

-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:

* 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.

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.

MENOPAUSE COHORT INCLUSION AND EXCLUSION CRITERIA

INCLUSION CRITERIA:

* Female, referring to sex assigned at birth (cis gender)
* Age 40 - 62 years
* Late perimenopausal or early postmenopausal status, defined by STRAW+10 criteria:
* Late perimenopause (Stage -1): Amenorrhea \>=60 days (2 cycles) in 12 months in the absence of other causes
* Early postmenopause (Stage +1a/+1b): Amenorrhea \>=12 months but \<=2 years since final menstrual period (FMP)
* History of regular menstrual cycles (consistent cycle length of 25 - 35 days) during the reproductive years (approximately 25-40 years of age), without medical intervention
* Ability of participant to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

* Previous surgery or procedure that induces amenorrhea or menopause

  * Prior hysterectomy (with ovarian conservation)
  * Prior bilateral oophorectomy
  * Prior endometrial ablation
  * Prior chemotherapy or pelvic radiation causing premature ovarian failure (unless age at menopause is clearly documented prior to intervention)
  * Current levonorgestrel-releasing intrauterine device (LNG-IUD)
* 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.
* Pregnant or breastfeeding
* 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.

Specific wash-out periods are required for evaluation of diagnosis or for exclusionary medications or supplements.

Where it's running

  • 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
  • Email: myniehs@nih.gov
  • Phone: (855) 696-4347

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.