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

September 15, 2017 updated by: Sandstone Diagnostics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91436
        • California Reproductive Services: Huntington Reproductive Center
      • Tarzana, California, United States, 91536
        • San Fernando Valley Urological Associates Medical Group
    • New York
      • Great Neck, New York, United States, 11021
        • Men's Fertility Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sperm Concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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.
Participants will be followed for one visit for up to 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Participants will be followed for one visit for up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandstone Diagnostics

Investigators

  • Principal Investigator: Eugene Dula, MD, San Fernando Valley Urological Associates Medical Group
  • Principal Investigator: Robert Boostanfar, MD, California Reproductive Services: Huntington Reproductive Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 2, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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