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

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.

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.