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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475395
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : July 21, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Sandstone Diagnostics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fertility, Male Sub-Fertility, Male Device: TRAK device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : September 2, 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Donor/Tester Subjects
Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen
 Device: TRAK device
Use of TRAK to attain sperm concentration measurement
Other Name: Sperm Concentration
Experimental: Tester Only Subjects
Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.
 Device: TRAK device
Use of TRAK to attain sperm concentration measurement
Other Name: Sperm Concentration


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users. [ Time Frame: 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.

  2. Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475395


Locations
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United States, California
California Reproductive Services: Huntington Reproductive Center
Encino, California, United States, 91436
San Fernando Valley Urological Associates Medical Group
Tarzana, California, United States, 91536
United States, New York
Men's Fertility Laboratory
Great Neck, New York, United States, 11021
Sponsors and Collaborators
Sandstone Diagnostics
Investigators
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Principal Investigator: Eugene Dula, MD San Fernando Valley Urological Associates Medical Group
Principal Investigator: Robert Boostanfar, MD California Reproductive Services: Huntington Reproductive Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sandstone Diagnostics
ClinicalTrials.gov Identifier: NCT02475395    
Other Study ID Numbers: SD001
First Posted: June 18, 2015    Key Record Dates
Results First Posted: July 21, 2017
Last Update Posted: October 18, 2017
Last Verified: September 2017
Keywords provided by Sandstone Diagnostics:
Male Fertility
Male Infertility
Fertility
Sperm
Sperm Concentration
Additional relevant MeSH terms:
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Infertility
Infertility, Male