Health TrialsbyHealthPanel

Sperm, Exposure and Endocrine Disruptors

ConditionsFertilityMale FertilitySperm Count, LowSperm Quality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorMillion Marker Wellness, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men,

Reproductive Age,

Good Health,

Non-Smoker

Disqualifiers

Women

Non-Reproductive Age

Poor Health

Smoker

Trial design

Design model

Parallel

Treatments tested in this trial

  • EDC Education Intervention

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Education InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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).

Time frame
12-weeks
2

Change in Sperm Count

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

Time frame
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.

Time frame
12 weeks
4

Change in Metabolites

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

Time frame
12 weeks

Secondary outcomes

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

Time frame
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

Time frame
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.

Time frame
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.

Time frame
12-weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Million Marker Wellness, Inc.

Lead sponsor

Fellow Health, Inc.

Collaborator

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: