Clinical trial NCT02475395: Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility, Male
Sub-Fertility, Male
Keywords: Male Fertility
Male Infertility
Fertility
Sperm
Sperm Concentration
Lead sponsor: Sandstone Diagnostics
Sponsor class: INDUSTRY
First posted: 2015-06-18
Enrollment: 272
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
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
timeFrame: Participants will be followed for one visit for up to 2 hours
Secondary outcomes:
measure: Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.
timeFrame: Participants will be followed for one visit for up to 2 hours
measure: Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.
timeFrame: Participants will be followed for one visit for up to 2 hours
Other outcomes:
Locations:
city: Encino
country: United States
facility: California Reproductive Services: Huntington Reproductive Center
state: California
city: Tarzana
country: United States
facility: San Fernando Valley Urological Associates Medical Group
state: California
city: Great Neck
country: United States
facility: Men's Fertility Laboratory
state: New York
Study officials:
affiliation: San Fernando Valley Urological Associates Medical Group
name: Eugene Dula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: California Reproductive Services: Huntington Reproductive Center
name: Robert Boostanfar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.