此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Sperm, Exposure and Endocrine Disruptors (SEED)

2026年10月30日 更新者:Jenna Hua、Million Marker Wellness, Inc.

Endocrine Disruptors and Men's Reproductive Health: A Randomized Behavioral Intervention to Increase Environmental Health Literacy and Reduce Exposures Among Men With Low Semen Quality

The proposed research aims to 1) measure male participants' urinary levels of EDCs and sperm quality before and after report-back and EDC reduction intervention and assess changes, 2) assess the extent to which MM's program (testing, curriculum, and report-back) alters participant environmental health literacy (EHL), readiness to change (RtC), and product/lifestyle choices, and 3) test the feasibility and acceptability of MM's program to male participants. The primary study subjects are adult men of reproductive age. The study aims to have 60 participants complete the study.

研究概览

详细说明

The SEED study hypothesizes that our report-back and intervention program will increase environmental health literacy and EDC-reduction behavior, reduce urinary EDCs, and improve semen quality in a sample of US men with low semen quality. And the intervention program will have a larger effect than report-back only. The study will consist of three Aims: 1) Measure male participants' urinary levels of EDCs and semen quality before and after report-back and EDC reduction intervention and assess change. 60 men, with previously established low semen quality, will be recruited from Legacy customers (a direct-to-consumer semen testing company). All participants' EDC exposures will be assessed via the MM test kit and receive personalized report-back. Subsequently, in a randomized-controlled trial, 30 participants (i.e. the intervention group) will engage in an 8-session online EDC environmental health literacy curriculum, as well as an online forum and coaching sessions, aimed to increase environmental health literacy and exposure reduction behavior. Thirty participants (i.e. the control group) will receive the report-back only. After completion of the curriculum, participants will retest urinary EDCs. Semen quality at these two time points will also be collected. Differences between the intervention and control groups will be assessed. 2) Assess the extent to which MM's program (testing, curriculum, and report-back) alters participant environmental health literacy, readiness to change, and product/lifestyle choices. Measures of environmental health literacy, willingness/readiness to reduce exposure, exposure reduction behavior, and sources of exposure will be assessed pre- and post-testing/intervention via previously validated surveys, including environmental health literacy and readiness to change (i.e. ready to reduce exposure), and lifestyle audits (including product use, diet, and lifestyle factors). Differences between the intervention and control groups will be assessed. 3) Test the feasibility and acceptability of MM's program to male participants. The usability, feasibility, and overall acceptability of the MM intervention program (i.e. testing, report-back, curriculum, coaching sessions) will be assessed in participants via the System Usability Score and other participant satisfaction questions. Further, focus groups and key informant interviews will be conducted in a subset of participants following the study to gather both qualitative and quantitative information to assess and improve the MM program.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • California
      • Berkeley、California、美国、94704
        • Million Marker Wellness Inc.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Men,
  • Reproductive Age,
  • Good Health,
  • Non-Smoker
  • English-Speaking
  • No Occupational/Medical Risks
  • not using steroids or TRT/hormone replacement supplements
  • low sperm count=total motile count below 20 million/ml

Exclusion Criteria:

  • Women
  • Non-Reproductive Age
  • Poor Health
  • Smoker
  • Non-English Speaking
  • Occupational/Medical Risks
  • using steroids or TRT/hormone replacement supplements
  • total motile count over 20 mil/ml

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Education Intervention

Study participants receive lifestyle audit and educational intervention program in addition to urine and sperm testing.

Participants receive a 14 module intervention program about endocrine disrupting chemicals and reducing exposures. Participants must complete at least 8 modules over the course of 8 weeks.

无干预:Control

Study participants receive urine and sperm testing only.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Environmental Health Literacy
大体时间:12-weeks

This surveys assesses EDC-specific environmental health literacy, based on questions in a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree) or 1 (never) to 5 (always). Responses will be reverse coded during analysis as needed so that higher numbers reflect positive outcomes (higher EDC-EHL).

12-weeks
Change in Sperm Count
大体时间:12 Weeks

Changes measured from Legacy Sperm Test- total motile count at the baseline and post intervention.

12 Weeks
Change in Readiness to Change
大体时间:12 weeks

The Readiness to Change question asks participants to choose the response (sentence) that most accurately describes their current efforts and interest in limiting their exposure to harmful chemicals. Responses will be coded from 1 to 5 with 5 reflecting greater readiness to reduce risky behaviors.

12 weeks
Change in Metabolites
大体时间:12 weeks

Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone.

12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in Sexual Satisfaction (From the International Index of Erectile Function (IIEF) Survey)
大体时间:12-weeks

Measured pre and post intervention to Likert style questions from 1 to 5 on overall self reported sexual satisfaction with higher score indicating more satisfied. Two questions taken from validated survey questions from the international index of erectile function survey including "how satisfied have you been with your overall sex life?" https://www.browardurologycenter.com/pdf/International-Index-of-Erectile-Function-IIEF-Questionnaire.pdf

12-weeks
Change in Sexual Health Inventory (SHIM)
大体时间:12-weeks

Validated survey measured pre and post intervention

Add the numbers corresponding to questions 1-5.

TOTAL:

The Sexual Health Inventory for Men further classifies ED severity with the following breakpoints:

1-7 Severe ED 8-11 Moderate ED 12-16 Mild to Moderate ED 17-21 Mild ED

12-weeks
Product Usage
大体时间:12 Weeks

Changes in # of reported product usage including personal care, household, and hair products with more products being worse and less products being better.

12 Weeks
System Usability Score (SUS)
大体时间:12-weeks

SUS is a validated survey measuring the usability of the intervention program at the end of intervention. The score is calculated from 0 to 100 with the greater the score indicating better perceived usability. Scores 60 and greater are considered acceptable.

12-weeks
Change in Stress
大体时间:12-weeks

Change in stress (from validated survey Perceived Stress Scale (PSS-4)). Summarize 4 questions for a score of 0-16. Higher score equals greater stress.

12-weeks
Intervention Completion
大体时间:At the end of intervention (12-weeks)

Number of total modules completed/requirements completed

At the end of intervention (12-weeks)
Change in General Health
大体时间:12 weeks

Change in self rated general health ( Behavioral Risk Factor Surveillance System (BRFSS)) "In general my health is" from very good to very bad (coded 1 to 5, 5 being very good). These variables are exploratory and may or may not be included in final analysis.

12 weeks
Change in Sleep
大体时间:12 weeks

Change in sleep (BRFSS- Behavioral Risk Factor Surveillance System), including self reported hours of sleep and sleep quality from very good to very bad(coded 1 to 5, 5 being very good). These variables are exploratory and may or may not be included in final analysis.

12 weeks
Change in Physical Activity
大体时间:12 Weeks

Change in physical activity (validated survey International Physical Activity Questionnaire (IPAQ)) using calculated MET (Metabolic Equivalent of Task) scores to classify into low, moderate or high physical activity (higher being better).

MET score = (how many days × how many minutes × how hard the activity is), added across all activity types." Walking= 3.3 METs Moderate activity=4.0 METs Vigorous activity=8.0 METs

These variables are exploratory and may or may not be included in final analysis.

12 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Johanna Rochester, PhD、Million Marker Wellness

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年6月26日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Million Marker will disseminate research results and findings to the scientific community through presentations at scientific meetings and conferences and publications in academic journals, as well as through the mass media and online postings. The Principal Investigator of this study will make data and associated documentation/metadata available to external researchers under a data-sharing agreement in which a specific commitment is made to use the data for research purposes only, to not provide the data to a third party or distribute it in any form, and to properly acknowledge the source of funding for the collection of the data and the researchers involved in this study.

IPD 共享时间框架

Starting six months after publication

IPD 共享访问标准

Researchers must submit an acceptable research plan (goals of the proposed research, the specific hypotheses to be examined, justification for research and methods), be affiliated with a recognized research institution, have demonstrated expertise in the area of the proposed research project, and receive independent approval from their governing institutional review board. Data will be available for use only to answer the specific question(s) indicated in the research plan. The researchers must provide a list of variable names and an outline of how research findings will be disseminated; and will be asked to sign a data-sharing agreement that commits to: 1) not attempt to identify any individual participant, 2) secure the data using appropriate software technology, 3) and destroy or return all data once analyses are complete. All final datasets will be de-identified. Final authorship on manuscripts will require review and approval by the Principal Investigators of this study.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅