Fertility, Male, Sub-Fertility, Male
Conditions
Keywords
Male Fertility, Male Infertility, Fertility, Sperm, Sperm Concentration
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.
Interventions
DEVICETRAK device
Use of TRAK to attain sperm concentration measurement
Sponsors
Sandstone Diagnostics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Men were recruited at three medical clinic sites from 2 September 2015 to 4 December 2015.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 258 |
| 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 | 14 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 30 | 3 |
Baseline characteristics
| Characteristic | Tester Only Subjects | Donor/Tester Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 258 Participants | 272 Participants |
| Age, Continuous | 33 years | 34 years | 34 years |
| Region of Enrollment United States | 14 participants | 258 participants | 272 participants |
| Sex: Female, Male Female | 14 Participants | 0 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 258 Participants | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 258 | 0 / 14 |
| serious Total, serious adverse events | 0 / 258 | 0 / 14 |
Outcome results
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.
Time frame: Participants will be followed for one visit for up to 2 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Donor/Tester Subjects | 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 | True Positive Trak Results | 52 Participants |
| Donor/Tester Subjects | 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 | True Negative Trak Results | 160 Participants |
| Donor/Tester Subjects | 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 | False Positive Trak Results | 10 Participants |
| Donor/Tester Subjects | 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 | False Negative Trak Results | 6 Participants |
| Tester Only Subjects | 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 | False Negative Trak Results | 0 Participants |
| Tester Only Subjects | 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 | True Positive Trak Results | 2 Participants |
| Tester Only Subjects | 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 | False Positive Trak Results | 2 Participants |
| Tester Only Subjects | 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 | True Negative Trak Results | 7 Participants |
95% CI: [79.9, 95.3]
95% CI: [88.7, 96.1]
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.
Time frame: Participants will be followed for one visit for up to 2 hours
Population: One fewer was analyzed in this population because a sample did not have enough sample to allow the HCP to run the test.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Donor/Tester Subjects | Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | True Positive Trak Results | 57 Participants |
| Donor/Tester Subjects | Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | True Negative Trak Results | 160 Participants |
| Donor/Tester Subjects | Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | False Positive Trak Results | 9 Participants |
| Donor/Tester Subjects | Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | False Negative Trak Results | 1 Participants |
| Tester Only Subjects | Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | False Negative Trak Results | 1 Participants |
| Tester Only Subjects | Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | True Positive Trak Results | 1 Participants |
| Tester Only Subjects | Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | False Positive Trak Results | 2 Participants |
| Tester Only Subjects | Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. | True Negative Trak Results | 7 Participants |
95% CI: [88.7, 99.1]
95% CI: [89.2, 96.5]
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.
Time frame: Participants will be followed for one visit for up to 2 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Donor/Tester Subjects | Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | True Positive Trak Results | 56 Participants |
| Donor/Tester Subjects | Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | True Negative Trak Results | 161 Participants |
| Donor/Tester Subjects | Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | False Positive Trak Results | 9 Participants |
| Donor/Tester Subjects | Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | False Negative Trak Results | 2 Participants |
| Tester Only Subjects | Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | False Negative Trak Results | 1 Participants |
| Tester Only Subjects | Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | True Positive Trak Results | 1 Participants |
| Tester Only Subjects | Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | False Positive Trak Results | 2 Participants |
| Tester Only Subjects | Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. | True Negative Trak Results | 7 Participants |
95% CI: [86.3, 98.3]
95% CI: [90.6, 97.3]