Fertility, MaleNCT02475395
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
A study testing TRAK device in people with Fertility, Male and Sub-Fertility, Male, run by Sandstone Diagnostics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fertility, Male, Sub-Fertility, Male
- What is being tested?
- TRAK device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Sep 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
California Reproductive Services: Huntington Reproductive Center
Encino, California, 91436
Men's Fertility Laboratory
Great Neck, New York, 11021
San Fernando Valley Urological Associates Medical Group
Tarzana, California, 91536
About this study
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
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.
- Conditions
- Fertility, Male, Sub-Fertility, Male
- Being tested
- TRAK device
- Keywords
- Male Fertility, Male Infertility, Fertility, Sperm, Sperm Concentration
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAK deviceDevice
Also called Sperm Concentration
Use of TRAK to attain sperm concentration measurement
| Study group | Role | What they receive |
|---|---|---|
| Donor/Tester Subjects | Experimental | Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen Receives: Device: TRAK device |
| Tester Only Subjects | Experimental | Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen. Receives: Device: TRAK device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for one visit for up to 2 hours
Secondary outcomes (2)
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.
Measured: 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.
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.
Measured: Participants will be followed for one visit for up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start2 Sep 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandstone Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Dula, MD, Principal investigator, San Fernando Valley Urological Associates Medical GroupRobert Boostanfar, MD, Principal investigator, California Reproductive Services: Huntington Reproductive Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475395
- Sponsor's protocol ID
- SD001
- Status last verified
- Sep 2017
- First submitted
- 9 Jun 2015
- Last updated
- 18 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 27887718
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02475395
- Acronym / sponsor ID
- SD001
- Conditions
- Fertility, Male, Sub-Fertility, Male
- Keywords
- Male Fertility, Male Infertility, Fertility, Sperm, Sperm Concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Sandstone DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Posted 21 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donor/Tester Subjects | Experimental | Device: TRAK deviceMale subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen |
| Tester Only Subjects | Experimental | Device: TRAK deviceMale or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAK deviceAlso: Sperm ConcentrationUse of TRAK to attain sperm concentration measurement | Device | Donor/Tester Subjects, Tester Only Subjects |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27887718Schaff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Dula, MD principal investigator
San Fernando Valley Urological Associates Medical Group
Robert Boostanfar, MD principal investigator
California Reproductive Services: Huntington Reproductive Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAK device in people with Fertility, Male and Sub-Fertility, Male, run by Sandstone Diagnostics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.