Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
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
1 other identifier
interventional
272
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedStudy Start
First participant enrolled
September 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
July 21, 2017
CompletedOctober 18, 2017
September 1, 2017
2 months
June 9, 2015
June 21, 2017
September 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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 Outcomes (2)
Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.
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.
Participants will be followed for one visit for up to 2 hours
Study Arms (2)
Donor/Tester Subjects
EXPERIMENTALMale subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen
Tester Only Subjects
EXPERIMENTALMale or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.
Interventions
Use of TRAK to attain sperm concentration measurement
Eligibility Criteria
You may qualify if:
- 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
- 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
- years of age inclusive
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
California Reproductive Services: Huntington Reproductive Center
Encino, California, 91436, United States
San Fernando Valley Urological Associates Medical Group
Tarzana, California, 91536, United States
Men's Fertility Laboratory
Great Neck, New York, 11021, United States
Related Publications (1)
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.
PMID: 27887718DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cheif Science Officer
- Organization
- Sandstone Diagnostics
Study Officials
- PRINCIPAL INVESTIGATOR
Eugene Dula, MD
San Fernando Valley Urological Associates Medical Group
- PRINCIPAL INVESTIGATOR
Robert Boostanfar, MD
California Reproductive Services: Huntington Reproductive Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 18, 2015
Study Start
September 2, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
October 18, 2017
Results First Posted
July 21, 2017
Record last verified: 2017-09