Sperm, Exposure and Endocrine Disruptors (SEED)
10 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jenna Hua, MPH, PhD
- Número de telefone: 510-305-5690
- E-mail: Jenna@millionmarker.com
Estude backup de contato
- Nome: Chris Ribbens
- E-mail: Chris@millionmarker.com
Locais de estudo
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California
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Berkeley, California, Estados Unidos, 94704
- Million Marker Wellness Inc.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Education Intervention
Study participants receive lifestyle audit and educational intervention program in addition to urine and sperm testing.
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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.
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Sem intervenção: Control
Study participants receive urine and sperm testing only.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Environmental Health Literacy
Prazo: 12-weeks
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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).
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12-weeks
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Change in Sperm Count
Prazo: 12 Weeks
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Changes measured from Fellow Sperm Test- total motile count at the baseline and post intervention.
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12 Weeks
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Change in Readiness to Change
Prazo: 12 weeks
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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.
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12 weeks
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Change in Metabolites
Prazo: 12 weeks
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Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone.
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12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Sexual Satisfaction (From the International Index of Erectile Function (IIEF) Survey)
Prazo: 12-weeks
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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
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12-weeks
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Change in Sexual Health Inventory (SHIM)
Prazo: 12-weeks
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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
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Product Usage
Prazo: 12 Weeks
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Changes in # of reported product usage including personal care, household, and hair products with more products being worse and less products being better.
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12 Weeks
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System Usability Score (SUS)
Prazo: 12-weeks
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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.
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12-weeks
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Change in Stress
Prazo: 12-weeks
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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.
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12-weeks
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Intervention Completion
Prazo: At the end of intervention (12-weeks)
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Number of total modules completed/requirements completed
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At the end of intervention (12-weeks)
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Change in General Health
Prazo: 12 weeks
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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.
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12 weeks
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Change in Sleep
Prazo: 12 weeks
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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.
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12 weeks
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Change in Physical Activity
Prazo: 12 Weeks
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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
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Johanna Rochester, PhD, Million Marker Wellness
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de junho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
26 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de julho de 2026
Primeira postagem (Real)
14 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R43ES036911
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
Starting six months after publication
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .