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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
272
Use of TRAK to attain sperm concentration measurement
California Reproductive Services: Huntington Reproductive Center
Encino, California, United States
San Fernando Valley Urological Associates Medical Group
Tarzana, California, United States
Men's Fertility Laboratory
Great Neck, New York, United States
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.
Time frame: Participants will be followed for one visit for up to 2 hours
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.
Time frame: 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.
Time frame: Participants will be followed for one visit for up to 2 hours
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