Laura Fredriksen, Jon Epperson, Kyungjin Hong, Gabriella Iacovetti, Ian Doig, Greg Sommer, Ulrich Schaff

Fertility and Sterility, Volume 110, Issue 4, e275

 

Objective: To develop a semen sample collection cup that passively measures ejaculate volume and provides an indication for hypospermia (<1.5 mL volume according to the WHO manual 5th edition). The Volume Cup is intended for home use by lay users as part of the Trak Male Fertility Testing System.

Design: The Volume Cup was designed with internal geometries that funnel the collected semen sample into a volume measurement chamber for visual interpretation. The cup is enzyme-coated to assist sample liquefaction. The cup’s analytical performance was validated via a method comparison study, an interpretive reader study, and a classroom-style user interpretation test. An additional study was conducted to determine if users could correctly interpret two semen analysis parameter test results without the aid of a healthcare professional.

Materials and Methods: Semen samples (N=232) were collected from consented human subjects directly into the Volume Cup, and tared weight measurement was used for gold standard volume measurement. Photographs of various volume results were presented to N=52 untrained, lay test subjects. N=32 additional test subjects were each presented with volume results challenging the 1.5 mL diagnostic cutoff. Lastly, N=27 test subjects were presented with both semen volume and sperm concentration results and asked to assess risk for subfertility based on clinical guidelines in the instructions for use.

Results: The Volume Cup’s sensitivity and specificity for user interpretation was found to be 94.2% (88.0 – 97.3%) and 97.7% (93.3 – 99.2%) with an overall percent agreement (OPA) of 96.1% (92.8 – 97.9%). Quantitative analysis of the data resulted in a linear trend with a best-fit r-square of 0.99. Users correctly interpreted increased risk for subfertility 100% (95.9 – 100.0%) of the time when presented with both semen volume and sperm concentration results. Additional analytical studies were also performed and determined that the unusual architecture of the cup would not interfere with other semen analysis parameters should the cup be used for sample collection before a semen analysis.

Conclusion: The Volume Cup provides an accurate assessment of hypospermia for lay users. Additionally, it was found that users could correctly interpret and understand more than one semen analysis parameter result without the aid of a healthcare professional.

Support: This study was funded by Sandstone Diagnostics, Inc.

References:

  1. World Health Organization. WHO laboratory manual for the examination and processing of human semen. 2010.
  2. Schaff UY, Fredriksen LL, Epperson JG, et al. Novel centrifugal technology for measuring sperm concentration in the home. Fertility and Sterility 2017; 107(2) 358-364
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