Trial Outcomes & Findings for Study of the Consumer Use of a New Home Test to Measure Sperm Concentration (NCT NCT02475395)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

272 participants

Primary outcome timeframe

Participants will be followed for one visit for up to 2 hours

Results posted on

2017-10-18

Participant Flow

Men were recruited at three medical clinic sites from 2 September 2015 to 4 December 2015.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	258	14
Overall Study COMPLETED	228	11
Overall Study NOT COMPLETED	30	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Protocol Violation	30	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Donor/Tester Subjects n=258 Participants 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	Tester Only Subjects n=14 Participants 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	Total n=272 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	258 Participants n=5 Participants	14 Participants n=7 Participants	272 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34 years n=5 Participants	33 years n=7 Participants	34 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	258 Participants n=5 Participants	0 Participants n=7 Participants	258 Participants n=5 Participants
Region of Enrollment United States	258 participants n=5 Participants	14 participants n=7 Participants	272 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Donor/Tester Subjects n=228 Participants 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	Tester Only Subjects n=11 Participants 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
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	2 Participants
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	7 Participants
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	2 Participants
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	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Donor/Tester Subjects n=228 Participants 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	Tester Only Subjects n=11 Participants 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
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	1 Participants
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	7 Participants
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	2 Participants
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	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Donor/Tester Subjects n=227 Participants 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	Tester Only Subjects n=11 Participants 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
Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. True Positive Trak Results	57 Participants	1 Participants
Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. True Negative Trak Results	160 Participants	7 Participants
Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. False Positive Trak Results	9 Participants	2 Participants
Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. False Negative Trak Results	1 Participants	1 Participants

Adverse Events

Donor/Tester Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tester Only Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cheif Science Officer

Sandstone Diagnostics

Phone: 9253157246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place