Fertility, Male Clinical Trial
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
| Verified date | September 2017 |
| Source | Sandstone Diagnostics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 272 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 50 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | California Reproductive Services: Huntington Reproductive Center | Encino | California |
| United States | Men's Fertility Laboratory | Great Neck | New York |
| United States | San Fernando Valley Urological Associates Medical Group | Tarzana | California |
| Lead Sponsor | Collaborator |
|---|---|
| Sandstone Diagnostics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | Participants will be followed for one visit for up to 2 hours | |
| Secondary | 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. | Participants will be followed for one visit for up to 2 hours |