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

Sandstone Diagnostics

Status: Completed

Conditions: Sub-Fertility, Male; Fertility, Male

Treatments: Device: TRAK device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02475395

SD001

Details and patient eligibility

About

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.

Enrollment: 272 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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272 participants in 2 patient groups

Donor/Tester Subjects

Experimental group

Description:

Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen

Treatment:

Device: TRAK device

Tester Only Subjects

Experimental group

Description:

Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.

Treatment:

Device: TRAK device