Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
NCT ID: NCT02475395
Last Updated: 2017-10-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
272 participants
INTERVENTIONAL
2015-09-02
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Donor/Tester Subjects
Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen
TRAK device
Use of TRAK to attain sperm concentration measurement
Tester Only Subjects
Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.
TRAK device
Use of TRAK to attain sperm concentration measurement
Interventions
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TRAK device
Use of TRAK to attain sperm concentration measurement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
50 Years
ALL
Yes
Sponsors
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Sandstone Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Eugene Dula, MD
Role: PRINCIPAL_INVESTIGATOR
San Fernando Valley Urological Associates Medical Group
Robert Boostanfar, MD
Role: PRINCIPAL_INVESTIGATOR
California Reproductive Services: Huntington Reproductive Center
Locations
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California Reproductive Services: Huntington Reproductive Center
Encino, California, United States
San Fernando Valley Urological Associates Medical Group
Tarzana, California, United States
Men's Fertility Laboratory
Great Neck, New York, United States
Countries
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References
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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.
Other Identifiers
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SD001
Identifier Type: -
Identifier Source: org_study_id