OBServation of Environment and ReproductiVe Endocrine Effects Study (OBSERVE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology.
研究概览
简要总结
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....
详细描述
Study Description:
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 research data, data secondary to clinical care and data regarding internal and external environmental exposures. We hypothesize that dysregulated environment is associated with reproductive and endocrine symptoms and dysfunction, and the clinical phenotype may evolve in response to treatment of the dysfunction.
Objectives:
- To study the hypothesis that external and internal environmental factors are associated with reproductive and endocrine symptoms and dysfunction
- To generate hypothesis for future studies investigating the impact of environment on human health
Endpoints:
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 8 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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.
排除标准
- 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
- 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.
- 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.
研究组 & 干预措施
Androgen Excess States- NOT Currently Recruiting[Recruitment may resume in the future.]
Polycystic Ovary Syndrome (PCOS); Women who meet criteria for PCOS based on NIH/ Rotterdam or other clinical criteria
Congenital Adrenal Hyperplasia - Currently Recruiting
Women with Congenital Adrenal Hyperplasia
Exhibiting signs of a diagnosis of hypogonadism- NOT Currently Recruiting
for example: Bosma arrhinia microphthalmia syndrome (BAMS)
Hyperandrogenism- NOT Currently Recruiting[Recruitment may resume in the future.]
Women who exhibit evidence of hyperandrogenism not related to Polycystic Ovarian Syndrome (PCOS); Extreme hyperinsulism, Idiopathic etc.
Hypogonadism / Infertility - NOT Currently Recruiting [Recruitment may resume in the future.]
Isolated hypogonadotropic hypogonadism
Hypothalamic Amenorrhea (female) Functional Hypogonadism (male) - NOT Currently Recruiting
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 - NOT Currently Recruiting[Recruitment may resume in the future.]
Reproductive disorders not related to the above categories. (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)
Perimenopause Menopause- Currently Recruiting[Recruitment may resume in the future.]
Perimenopausal women are those typically above age 40 years and experience secondary amenorrhea/ oligomenorrhea for two cycles ( at least 60 days ) in the last 12 months, as defined by the STRAW+10 criteria. Menopausal women have amenorrhea for at least 12 months.
Precocious or Delayed Puberty - NOT Currently Recruiting[Recruitment may resume in the future.]
Participants who display clinical evidence of delayed or precocious puberty based on standard criteria.
Premature Ovarian Insufficiency - NOT Currently Recruiting [Recruitment may resume in the future.]
Women who attain menopause before age 40 years (or as defined by clinical criteria).
Weight *Overweight/Underweight - NOT Currently Recruiting [Recruitment may resume in the future.]
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.
结局指标
主要结局
Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology.
时间窗: at baseline and after clinical care for the underlying condition
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.
次要结局
- Greater exposure to EDCs will be associated with increased hot flash frequency in perimenopausal and menopausal women.(at baseline, month 2 and month 4)
- the relationship between nutrition, diet and reproduction(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)
- the impact of stress on reproductive dysfunction(at baseline and after clinical care for the underlying condition)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06280807
- 其他研究编号
- 10001617, 001617-E
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (12年后)
- 研究完成日期
- (12年后)
- 最近核实
- (6天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Aggregated and summarized data will be made available as part of associated publication, using NIH-Supported Data Sharing Resources (nlm.nih.gov/NIHbmic/generalist_repositories.html ). Aggregated summary and statistical analysis will be publicly available. All the patient-level data will require controlled access. Outside investigators may apply for research collaborations related to the original research questions, that will be IRB approved for use and a data transfer agreement will be signed, and coded, deidentified data will be provided with a data dictionary. For studies unrelated to the original research, only deidentified data can be provided and only when subjects consented to future research. Summary clinical response and adverse event data will be placed in clinicaltrials.gov one year after the final subject has completed the primary endpoint.