Study of the Consumer Use of a New Home Test to Measure Sperm Concentration

Study Overview
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Brief Summary
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The objective of the study is to evaluate the agreement in measurement of sperm concentration in human semen between lay users with TRAK and a recognized reference method. The study will also include the measurement of matched samples by TRAK when tested by healthcare professionals trained in use of the TRAK device.

Official Title
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A Clinical Study Evaluating Consumer Use of a New Device (TRAK) to Measure Sperm Concentration From Human Semen Samples, and Comparing TRAK Test Results With Laboratory Reference Method Testing

Conditions
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Fertility, Male, Sub-Fertility, Male

Intervention / Treatment
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* Device: TRAK device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects (Donor/Tester) Generally healthy (apart from fertility or reproductive care), ambulatory, and have absence of chronic conditions or treatments, except those related to fertility and reproductive care 20 - 50 years of age inclusive Male sex (subjects providing and/or testing human semen specimens) For males providing human semen specimens, either healthy subjects or men receiving health care for any one or more of the following reasons: Partner in a couple having difficulty conceiving Diagnosed with male factor infertility Post-vasectomy patients Post-vasectomy reversal patients Testers Only Be able to provide signed Informed Consent 20 - 50 years of age inclusive Exclusion Criteria: Any medical or personal issue that would impair the ability of the subject to adhere to the protocol (e.g. substance abuse, neurological disorders) Patients currently taking investigational drugs or who are active participants in a treatment trial for any condition Unable to speak, understand, or write English Mental illness that would interfere with understanding during the discussion of Informed Consent or that would compromise ability to follow the study protocol including, but not limited to, review of the TRAK™ Instructional Booklet, semen specimen collection, and semen specimen testing.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donor/Tester Subjects<br>Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen | Device: TRAK device<br>* Use of TRAK to attain sperm concentration measurement<br>* Other names: Sperm Concentration;|
| Experimental: Tester Only Subjects<br>Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen. | Device: TRAK device<br>* Use of TRAK to attain sperm concentration measurement<br>* Other names: Sperm Concentration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Untrained Lay Users That Obtained Accurate and Inaccurate Subfertility Results From the TRAK Device When Compared to Results Obtained From the Gold Standard | Lay users obtained categorical sperm concentration result. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Gold standard reference (analysis by Computer-aided Semen Analysis [CASA]) result was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match gold standard reference category result. | Participants will be followed for one visit for up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | Healthcare professions obtained a categorical sperm concentration result by observing completed assay outputs as performed by Lay Users. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result. | Participants will be followed for one visit for up to 2 hours | 
| Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | Healthcare professions obtained a categorical sperm concentration result by performing assay on aliquot obtained from Lay User's sample. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result. | Participants will be followed for one visit for up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Fertility, Male Infertility, Fertility, Sperm Concentration, Sperm