Back to resultsStudy of the Consumer Use of a New Home Test to Measure Sperm Concentration
Primary Purpose
Fertility, Male, Sub-Fertility, Male
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRAK device
Sponsored by
About this trial
This is an interventional diagnostic trial for Fertility, Male focused on measuring Male Fertility, Male Infertility, Fertility, Sperm, Sperm Concentration
Eligibility Criteria
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.
Sites / Locations
- California Reproductive Services: Huntington Reproductive Center
- San Fernando Valley Urological Associates Medical Group
- Men's Fertility Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Donor/Tester Subjects
Tester Only Subjects
Arm Description
Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen
Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02475395
Brief Title
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
Official Title
A Clinical Study Evaluating Consumer Use of a New Device (TRAK) to Measure Sperm Concentration From Human Semen Samples, and Comparing TRAK Test Results With Laboratory Reference Method Testing
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2, 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandstone Diagnostics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility, Male, Sub-Fertility, Male
Keywords
Male Fertility, Male Infertility, Fertility, Sperm, Sperm Concentration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Donor/Tester Subjects
Arm Type
Experimental
Arm Description
Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen
Arm Title
Tester Only Subjects
Arm Type
Experimental
Arm Description
Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.
Intervention Type
Device
Intervention Name(s)
TRAK device
Other Intervention Name(s)
Sperm Concentration
Intervention Description
Use of TRAK to attain sperm concentration measurement
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.
Description
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
Title
Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Dula, MD
Organizational Affiliation
San Fernando Valley Urological Associates Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Boostanfar, MD
Organizational Affiliation
California Reproductive Services: Huntington Reproductive Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Reproductive Services: Huntington Reproductive Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
San Fernando Valley Urological Associates Medical Group
City
Tarzana
State/Province
California
ZIP/Postal Code
91536
Country
United States
Facility Name
Men's Fertility Laboratory
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27887718
Citation
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.
Results Reference
derived
Learn more about this trial
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
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