Sperm, Exposure and Endocrine Disruptors (SEED)

July 10, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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 Fellow Health 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Million Marker Wellness Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • tested by Fellow in the last 3 months

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, tested by Fellow over 3 months ago

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education Intervention
Study participants receive lifestyle audit and educational intervention program in addition to urine and sperm testing.
Behavioral: EDC Education Intervention
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.
No Intervention: Control
Study participants receive urine and sperm testing only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Environmental Health Literacy
Time Frame: 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
Time Frame: 12 Weeks
Changes measured from Fellow Sperm Test- total motile count at the baseline and post intervention.
12 Weeks
Change in Readiness to Change
Time Frame: 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
Time Frame: 12 weeks
Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sexual Satisfaction (From the International Index of Erectile Function (IIEF) Survey)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Million Marker Wellness, Inc.

Collaborators

National Institute of Environmental Health Sciences (NIEHS)
Fellow Health, Inc.

Investigators

  • Study Director: Johanna Rochester, PhD, Million Marker Wellness

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R43ES036911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

Starting six months after publication

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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