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FertilitySEEDNCT07703046

Sperm, Exposure and Endocrine Disruptors

A study testing EDC Education Intervention in people with Fertility and Male Fertility, run by Million Marker Wellness, Inc. at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Fertility, Male Fertility, Sperm Count, Low
What is being tested?
EDC Education Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
Nov 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men,
  • Reproductive Age,
  • Good Health,
  • Non-Smoker
  • English-Speaking
  • No Occupational/Medical Risks
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jenna Hua, MPH, PhD contact

510-305-5690

Jenna@millionmarker.com

Chris Ribbens contact

Chris@millionmarker.com

United States1 site

  • Million Marker Wellness Inc.

    Berkeley, California, 94704

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
EDC Education Intervention
Keywords
EDCs, Endocrine Disrupting Chemicals, Fertility, Sperm Quality, Sperm Count, Male Fertility
Medical subject headings
Oligospermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EDC Education InterventionBehavioural

    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.

Study groups in NCT07703046
Study groupRoleWhat they receive
Education InterventionExperimentalStudy participants receive lifestyle audit and educational intervention program in addition to urine and sperm testing.
Receives: Behavioral: EDC Education Intervention
ControlNo interventionStudy participants receive urine and sperm testing only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12-weeks

  2. Change in Sperm Count

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

    Measured: 12 Weeks

  3. 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.

    Measured: 12 weeks

  4. Change in Metabolites

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

    Measured: 12 weeks

Secondary outcomes (9)

  1. 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

    Measured: 12-weeks

  2. 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

    Measured: 12-weeks

  3. 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.

    Measured: 12 Weeks

  4. 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.

    Measured: 12-weeks

  5. 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.

    Measured: 12-weeks

  6. Intervention Completion

    Number of total modules completed/requirements completed

    Measured: At the end of intervention (12-weeks)

  7. 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.

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

  9. 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.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07703046
Sponsor's protocol ID
1R43ES036911
Acronym
SEED
Status last verified
Oct 2026
First submitted
26 Jun 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Sharma A, Mollier J, Brocklesby RWK, Caves C, Jayasena CN, Minhas S. Endocrine-disrupting chemicals and male reproductive health. Reprod Med Biol. 2020 Apr 14;19(3):243-253. doi: 10.1002/rmb2.12326. eCollection 2020 Jul.

    PubMed 32684823

  • Finn S, O'Fallon L. The Emergence of Environmental Health Literacy-From Its Roots to Its Future Potential. Environ Health Perspect. 2017 Apr;125(4):495-501. doi: 10.1289/ehp.1409337. Epub 2015 Jun 30.

    PubMed 26126293

  • Rochester JR, Kwiatkowski CF, Lathrop MK, Neveux I, Daza EJ, Grzymski J, Hua J. Reducing Exposures to Endocrine Disruptors (REED) study, a personalized at-home intervention program to reduce exposure to endocrine disrupting chemicals among a child-bearing age cohort: study protocol for a randomized controlled trial. Trials. 2024 Nov 25;25(1):793. doi: 10.1186/s13063-024-08627-3.

    PubMed 39587613

  • Rochester JR, Kwiatkowski CF, Neveux I, Dabe S, Hatcher KM, Lathrop MK, Daza EJ, Eskenazi B, Grzymski JJ, Hua J. A Personalized Intervention to Increase Environmental Health Literacy and Readiness to Change in a Northern Nevada Population: Effects of Environmental Chemical Exposure Report-Back. Int J Environ Res Public Health. 2024 Jul 11;21(7):905. doi: 10.3390/ijerph21070905.

    PubMed 39063482

  • Hauser R, Skakkebaek NE, Hass U, Toppari J, Juul A, Andersson AM, Kortenkamp A, Heindel JJ, Trasande L. Male reproductive disorders, diseases, and costs of exposure to endocrine-disrupting chemicals in the European Union. J Clin Endocrinol Metab. 2015 Apr;100(4):1267-77. doi: 10.1210/jc.2014-4325. Epub 2015 Mar 5.

    PubMed 25742517

  • Cannarella R, Gul M, Rambhatla A, Agarwal A. Temporal decline of sperm concentration: role of endocrine disruptors. Endocrine. 2023 Jan;79(1):1-16. doi: 10.1007/s12020-022-03136-2. Epub 2022 Oct 4.

    PubMed 36194343

  • Gore AC, Chappell VA, Fenton SE, Flaws JA, Nadal A, Prins GS, Toppari J, Zoeller RT. EDC-2: The Endocrine Society's Second Scientific Statement on Endocrine-Disrupting Chemicals. Endocr Rev. 2015 Dec;36(6):E1-E150. doi: 10.1210/er.2015-1010. Epub 2015 Nov 6.

    PubMed 26544531

  • Rochester JR. Bisphenol A and human health: a review of the literature. Reprod Toxicol. 2013 Dec;42:132-55. doi: 10.1016/j.reprotox.2013.08.008. Epub 2013 Aug 30.

    PubMed 23994667

  • Green MP, Harvey AJ, Finger BJ, Tarulli GA. Endocrine disrupting chemicals: Impacts on human fertility and fecundity during the peri-conception period. Environ Res. 2021 Mar;194:110694. doi: 10.1016/j.envres.2020.110694. Epub 2020 Dec 30.

    PubMed 33385395

  • Harley KG, Kogut K, Madrigal DS, Cardenas M, Vera IA, Meza-Alfaro G, She J, Gavin Q, Zahedi R, Bradman A, Eskenazi B, Parra KL. Reducing Phthalate, Paraben, and Phenol Exposure from Personal Care Products in Adolescent Girls: Findings from the HERMOSA Intervention Study. Environ Health Perspect. 2016 Oct;124(10):1600-1607. doi: 10.1289/ehp.1510514. Epub 2016 Mar 7.

    PubMed 26947464

  • Trasande L, Zoeller RT, Hass U, Kortenkamp A, Grandjean P, Myers JP, DiGangi J, Hunt PM, Rudel R, Sathyanarayana S, Bellanger M, Hauser R, Legler J, Skakkebaek NE, Heindel JJ. Burden of disease and costs of exposure to endocrine disrupting chemicals in the European Union: an updated analysis. Andrology. 2016 Jul;4(4):565-72. doi: 10.1111/andr.12178. Epub 2016 Mar 22.

    PubMed 27003928

  • Attina TM, Hauser R, Sathyanarayana S, Hunt PA, Bourguignon JP, Myers JP, DiGangi J, Zoeller RT, Trasande L. Exposure to endocrine-disrupting chemicals in the USA: a population-based disease burden and cost analysis. Lancet Diabetes Endocrinol. 2016 Dec;4(12):996-1003. doi: 10.1016/S2213-8587(16)30275-3. Epub 2016 Oct 17.

    PubMed 27765541

  • Giulivo M, Lopez de Alda M, Capri E, Barcelo D. Human exposure to endocrine disrupting compounds: Their role in reproductive systems, metabolic syndrome and breast cancer. A review. Environ Res. 2016 Nov;151:251-264. doi: 10.1016/j.envres.2016.07.011. Epub 2016 Aug 7.

    PubMed 27504873

Questions about this trial

What is this clinical trial studying?

A study testing EDC Education Intervention in people with Fertility and Male Fertility, run by Million Marker Wellness, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jenna Hua, MPH, PhD (510-305-5690, Jenna@millionmarker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Environmental Health Literacy (time frame: 12-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07703046, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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