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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

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.

Arm && Interventions

Group	Intervention	Description
Tester Only Subjects	TRAK device	Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.
Donor/Tester Subjects	TRAK device	Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen

Primary Outcome Measures

Name	Time	Method
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	Participants will be followed for one visit for up to 2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.	Participants will be followed for one visit for up to 2 hours	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.
Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.	Participants will be followed for one visit for up to 2 hours	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.

Locations (3): California Reproductive Services: Huntington Reproductive Center
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Encino, California, United States
San Fernando Valley Urological Associates Medical Group
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Tarzana, California, United States
Men's Fertility Laboratory
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Great Neck, New York, United States