Study of the Consumer Use of a New Home Test to Measure Sperm Concentration

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.