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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donor/Tester Subjects | Experimental | Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen |
|
| Tester Only Subjects | Experimental | Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRAK device | Device | Use of TRAK to attain sperm concentration measurement |
|
| 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 |
| 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. |
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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:
Testers Only
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Dula, MD | San Fernando Valley Urological Associates Medical Group | Principal Investigator |
| Robert Boostanfar, MD | California Reproductive Services: Huntington Reproductive Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Reproductive Services: Huntington Reproductive Center | Encino | California | 91436 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27887718 | Derived | Schaff UY, Fredriksen LL, Epperson JG, Quebral TR, Naab S, Sarno MJ, Eisenberg ML, Sommer GJ. Novel centrifugal technology for measuring sperm concentration in the home. Fertil Steril. 2017 Feb;107(2):358-364.e4. doi: 10.1016/j.fertnstert.2016.10.025. Epub 2016 Nov 22. |
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Men were recruited at three medical clinic sites from 2 September 2015 to 4 December 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Donor/Tester Subjects | Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen TRAK device: Use of TRAK to attain sperm concentration measurement |
| FG001 | Tester Only Subjects | Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen TRAK device: Use of TRAK to attain sperm concentration measurement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Donor/Tester Subjects | Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen TRAK device: Use of TRAK to attain sperm concentration measurement |
| BG001 | Tester Only Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Participants will be followed for one visit for up to 2 hours |
|
2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donor/Tester Subjects | Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen TRAK device: Use of TRAK to attain sperm concentration measurement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheif Science Officer | Sandstone Diagnostics | 9253157246 | 925 | gsommer@sandstonedx.com |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| 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 |
| San Fernando Valley Urological Associates Medical Group |
| Tarzana |
| California |
| 91536 |
| United States |
| Men's Fertility Laboratory | Great Neck | New York | 11021 | United States |
Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Tester Only Subjects | Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen TRAK device: Use of TRAK to attain sperm concentration measurement |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Participants will be followed for one visit for up to 2 hours |
|
|
|
|
| Secondary | 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. | One fewer was analyzed in this population because a sample did not have enough sample to allow the HCP to run the test. | Posted | Count of Participants | Participants | Participants will be followed for one visit for up to 2 hours |
|
|
|
|
| 0 |
| 258 |
| 0 |
| 258 |
| EG001 | Tester Only Subjects | Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen TRAK device: Use of TRAK to attain sperm concentration measurement | 0 | 14 | 0 | 14 |
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| D052801 |
| Male Urogenital Diseases |
| False Positive Trak Results |
|
| False Negative Trak Results |
|
| 94.9 |
| 2-Sided |
| 95 |
| 90.6 |
| 97.3 |
| Other |
| False Positive Trak Results |
|
| False Negative Trak Results |
|
| 93.8 |
| 2-Sided |
| 95 |
| 89.2 |
| 96.5 |
| Other |