An interventional study of EDC Education Intervention in Fertility, Male Fertility and Sperm Count, Low, sponsored by Million Marker Wellness, Inc.. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Million Marker Wellness, Inc. · Not applicable, Interventional, and Treatment
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.
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.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 46 interventional studies indexed under Oligospermia.
Browse Oligospermia studies →Million Marker Wellness, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 3, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study participants receive lifestyle audit and educational intervention program in addition to urine and sperm testing.
Behavioral: EDC Education Intervention
Study participants receive urine and sperm testing only.
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.
Change in Environmental Health Literacy
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).
Time frame: 12-weeks
Change in Sperm Count
Changes measured from Legacy Sperm Test- total motile count at the baseline and post intervention.
Time frame: 12 Weeks
Change in Readiness to Change
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.
Time frame: 12 weeks
Change in Metabolites
Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone.
Time frame: 12 weeks
Change in Sexual Satisfaction (From the International Index of Erectile Function (IIEF) Survey)
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
Time frame: 12-weeks
Change in Sexual Health Inventory (SHIM)
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
Time frame: 12-weeks
Product Usage
Changes in # of reported product usage including personal care, household, and hair products with more products being worse and less products being better.
Time frame: 12 Weeks
System Usability Score (SUS)
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.
Time frame: 12-weeks
Change in Stress
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.
Time frame: 12-weeks
Intervention Completion
Number of total modules completed/requirements completed
Time frame: At the end of intervention (12-weeks)
Change in General Health
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.
Time frame: 12 weeks
Change in Sleep
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.
Time frame: 12 weeks
Change in Physical Activity
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.
Time frame: 12 Weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Starting six months after publication
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Million Marker Wellness, Inc.