Novel centrifugal technology for measuring sperm concentration in the home

The newly US Food and Drug Administration-cleared Trak System was shown to be an accurate tool for categorically measuring sperm concentration in the home.

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Volume 107, Issue 2, Pages 358–364

Authors:

Ulrich Y. Schaff, Ph.D., Laura L. Fredriksen, M.S., Jon G. Epperson, B.S., Tiffany R. Quebral, B.A., Sara Naab, M.S.I., Mark J. Sarno, E.J.D., Michael L. Eisenberg, M.D., Greg J. Sommer, Ph.D.

Abstract:

Objective

To evaluate the analytical performance and usability of the Trak Male Fertility Testing System, a semiquantitative (categorical) device recently US Food and Drug Administration (FDA)-cleared for measuring sperm concentration in the home by untrained users.

Design

A three-site clinical trial comparing self-reported lay user results versus reference results obtained by computer-aided semen analysis (CASA).

Setting

Simulated home use environments at fertility centers and urologist offices.

Patient(s)

A total of 239 untrained users.

Intervention(s)

None.

Main Outcome Measure(s)

Sperm concentration results reported from self-testing lay users and laboratory reference method by CASA were evaluated semiquantitatively against the device's clinical cutoffs of 15 M/mL (current World Health Organization cutoff) and 55 M/mL (associated with faster time to pregnancy). Additional reported metrics include assay linearity, precision, limit of detection, and ease-of-use ratings from lay users.

Result(s)

Lay users achieved an accuracy (versus the reference) of 93.3% (95% confidence interval [CI] 84.1%–97.4%) for results categorized as ≤15 M/mL, 82.4% (95% CI 73.3%–88.9%) for results categorized as 15–55 M/mL, and 95.5% (95% CI 88.9%–98.2%) for results categorized as >55 M/mL. When measured quantitatively, Trak results had a strong linear correlation with CASA measurements (r = 0.99). The precision and limit of detection studies show that the device has adequate reproducibility and detection range for home use. Subjects generally rated the device as easy to use.

Conclusion(s)

The Trak System is an accurate tool for semiquantitatively measuring sperm concentration in the home. The system may enable screening and longitudinal assessment of sperm concentration at home.

Clinical Trial Registration Number

ClinicalTrials.gov identifier: NCT02475395.


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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

2 Comments

Go to the profile of Jason Kovac
Jason Kovac over 3 years ago

Any type of home sperm testing can serve indirect benefit and harm. For those couples encountering reproductive endocrinologists that do not refer the male, this can give the couple a reason for initiating contact with a urologist. However if the test registers a normal, intervention might not be pursued. Accuracy of such testing should include this consideration.

Go to the profile of T. Mike Hsieh
T. Mike Hsieh over 3 years ago

Home sperm testing gives a discreet method of fertility testing for men. this novel system appears to be able to accurately interpret sperm concentration. as mentioned in the discussion, other factors of sperm function isn't available in the system which greatly reduce the ability to predict fertility. For now, this appears to be a quick point-of-care testing for post vasectomy check only. my question for the authors is whether a 2.0 version of the system with ability to determine motility and morphology will be in development?