Sperm, Exposure and Endocrine Disruptors

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Change in Environmental Health Literacy [Time frame: 12-weeks]
• Change in Sperm Count [Time frame: 12 Weeks]
• Change in Readiness to Change [Time frame: 12 weeks]
• Change in Metabolites [Time frame: 12 weeks]

Secondary outcome measures (9)

• Change in Sexual Satisfaction (From the International Index of Erectile Function (IIEF) Survey) [Time frame: 12-weeks]
• Change in Sexual Health Inventory (SHIM) [Time frame: 12-weeks]
• Product Usage [Time frame: 12 Weeks]
• System Usability Score (SUS) [Time frame: 12-weeks]
• Change in Stress [Time frame: 12-weeks]
• Intervention Completion [Time frame: At the end of intervention (12-weeks)]
• Change in General Health [Time frame: 12 weeks]
• Change in Sleep [Time frame: 12 weeks]
• Change in Physical Activity [Time frame: 12 Weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Million Marker Wellness Inc. — Berkeley

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 23994667

Identifiers

NCT: NCT07703046 · 1R43ES036911

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗