At-home sperm testing for epidemiologic studies: Evaluation of the Trak male fertility testing system in an internet-based preconception cohort

Greg J Sommer, Tanran R Wang, Jon G Epperson, Elizabeth E Hatch, Amelia K Wesselink, Kenneth J Rothman, Laura L Fredriksen, Ulrich Y Schaff, Barry Behr, Michael L Eisenberg, Lauren A Wise, Greg J Sommer, Tanran R Wang, Jon G Epperson, Elizabeth E Hatch, Amelia K Wesselink, Kenneth J Rothman, Laura L Fredriksen, Ulrich Y Schaff, Barry Behr, Michael L Eisenberg, Lauren A Wise

Abstract

Background: Semen quality assessment in population-based epidemiologic studies presents logistical and financial challenges due to reliance on centralised laboratory semen analysis. The Trak Male Fertility Testing System is an FDA-cleared and validated at-home test for sperm concentration and semen volume, with a research use only sperm motility test. Here we evaluate the Trak System's overall utility among men participating in Pregnancy Study Online (PRESTO), a web-based study of North American couples planning pregnancy.

Methods: US male participants aged ≥21 years with ≤6 months of pregnancy attempt time at study enrolment were invited to participate in the semen testing substudy after completing their baseline questionnaire. Consenting participants received a Trak Engine (battery-powered centrifuge) and two test kits. Participants shared their test results via smartphone images uploaded to online questionnaires. Data were then linked with covariate data from the baseline questionnaire.

Results: Of the 688 men invited to participate, 373 (54%) provided consent and 271 (73%) completed at least one semen test result. The distributions of semen volume, sperm concentration, motile sperm concentration, total sperm count, and total motile sperm count were similar to 2010 World Health Organization (WHO) semen parameter data of men in the general population. The overall usability score for the Trak System was 1.4 on a 5-point Likert scale (1 = Very Easy, 5 = Difficult), and 92% of participants believed they performed the test correctly and received an accurate result. Lastly, men with higher motile sperm count were more likely to report feeling "at ease" or "excited" following testing, while men with low motile sperm count were more likely to report feeling "concerned" or "frustrated." Overall, 91% of men reported they would like to test again.

Conclusions: The Trak System provides a simple and potentially cost-effective means of measuring important semen parameters and may be useful in population-based epidemiologic fertility studies.

© 2019 John Wiley & Sons Ltd.

Figures

FIGURE 1
FIGURE 1
Trak Male Fertility Testing System overview. A, Trak Engine, Prop, Volume Collection Cup, and Sample Dropper. B, Sperm concentration results—sperm cells concentrate in the outer measurement window of the Prop during the 5-minute spin in the Trak Engine. The visual height of the white sperm cell pellet directly correlates with sperm concentration, as shown in the plot comparing Trak results with gold standard laboratory measurements via computer-aided semen analysis (CASA). C, The Trak Volume Collection Cup provides a measurement of semen volume between 0 and 6 mL by funnelling the sample into the graduated volume measurement window
FIGURE 2
FIGURE 2
PRESTO/Trak semen testing substudy design
FIGURE 3
FIGURE 3
Trak System testing and reporting steps
FIGURE 4
FIGURE 4
Participant evaluation of the ease of use for each test step via Likert scale

References

    1. American Urological Association. The optimal evaluation of the infertile man. (2010).
    1. WHO. WHO laboratory manual for the examination and processing of human semen. 5th Edition. Geneva, Switzerland: WHO. 2010.
    1. Bjorndahl L, Mortimer D, Barratt CLR, et al. A Practical Guide to Basic Laboratory Andrology. Cambridge: Cambridge University Press; 2010.
    1. Yu S, Rubin M, Geevarughese S, Pino JS, Rodriguez HF, Asghar W. Emerging technologies for home-based semen analysis. Andrology. 2018;6:10–19.
    1. Pottinger AM, Carroll K, Mason G. Male attitude towards masturbating: an impediment to infertility evaluation and sperm parameters. Andrologia. 2016;48:774–778.
    1. Martín Rivera-Montes A, Rivera-Gallegos A, Rodríguez-Villasana E, et al. Estimate of the variability in the evaluation of semen analysis. Ginecol Obstet Mex 2013;81:639–64 4.
    1. Filimberti E, Degl’Innocenti S, Borsotti M, et al. High variability in results of semen analysis in andrology laboratories in Tuscany (Italy): the experience of an external quality control (EQC) programme. Andrology. 2013;1:401–407.
    1. Barratt CLR, De Jonge CJ, Sharpe RM. ‘Man Up’: the importance and strategy for placing male reproductive health centre stage in the political and research agenda. Hum Reprod. 2018;33:541–545.
    1. Leung AK, Henry MA, Mehta A. Gaps in male infertility health services research. Transl Androl Urol. 2018;7:S303–S309.
    1. Buck Louis GM, Schisterman EF, Sweeney AM, et al. Designing prospective cohort studies for assessing reproductive and developmental toxicity during sensitive windows of human reproduction and development–the LIFE Study. Paediatr Perinat Epidemiol. 2011;25:413–424.
    1. Buck Louis GM, Sundaram R, Schisterman EF, et al. Semen quality and time to pregnancy: the Longitudinal Investigation of Fertility and the Environment Study. Fertil Steril. 2014;101:453–462.
    1. Eisenberg ML, Kim S, Chen Z, et al. The relationship between male BMI and waist circumference on semen quality: data from the LIFE study. Hum Reprod. 2014;29:193–200.
    1. Bonde JPE, Ernst E, Jensen TK, et al. Relation between semen quality and fertility: a population-based study of 430 first-pregnancy planners. Lancet. 1998;352:1172–1177.
    1. Eisenberg ML, Li S, Behr B, et al. Semen quality, infertility and mortality in the USA. Hum Reprod. 2014;29:1567–1574.@@@
    1. Walsh TJ, Schembri M, Turek PJ, et al. Increased risk of high-grade prostate cancer among infertile men. Cancer. 2010;116:2140–2147.
    1. Eisenberg ML, Park Y, Hollenbeck AR, et al. Fatherhood and the risk of cardiovascular mortality in the NIH-AARP Diet and Health Study. Hum Reprod. 2011;26:3479–3485.
    1. Wise LA, Rothman KJ, Mikkelsen EM, et al. Design and conduct of an internet-based preconception cohort study in North America: pregnancy study online. Paediatr Perinat Epidemiol. 2015;29:360–371.
    1. Wise LA, Rothman KJ, Wesselink AK, et al. Male sleep duration and fecundability in a North American preconception cohort study. Fertil Steril. 2018;109:453–459.
    1. Wesselink AK, Hatch EE, Rothman KJ, et al. Prospective study of cigarette smoking and fecundability. Hum Reprod. 2018;34:558–567.
    1. Aschengrau A, Hatch EE, Rothman KJ, et al. Perceived stress and fecundability: a preconception cohort study of North American couples. Am J Epidemiol. 2018;187:2662–2671.
    1. Hatch EE, Wesselink AK, Hahn KA, et al. Intake of sugar-sweetened beverages and fecundability in a North American preconception cohort. Epidemiology. 2018;29:369–378.
    1. Schaff UY, Fredriksen LL, Epperson JG, et al. Novel centrifugal technology for measuring sperm concentration in the home. Fertil Steril. 2017;107:358–364.e4.
    1. Sommer G, Wesselink A, Trinidad T, et al. Using an in-home semen testing system to evaluate total sperm count and time to conception: a pilot study. Fertil Steril. 2017;108:e79–e80.
    1. Fredriksen LL, Epperson J, Hong K, et al. Design and validation of the trak® volume cup - a dual purpose semen collection and volume measurement device for diagnosing hypospermia. Fertil Steril. 2018;110:e275.
    1. Fredriksen LL, Epperson J, Sommer G, Schaff U. Development of an at-home sperm motility assay. Fertil Steril. 2018;110:e306.
    1. Centers for Disease Control and Prevention, S. for A. R. T. Defining Adult Over weight and Obesity. 2019.
    1. Cooper TG, Noonan E, von Eckardstein S, et al. World Health Organization reference values for human semen characteristics. Hum Reprod Update. 2010;16:231–245.
    1. Zinaman MJ, Brown CC, Selevan SG, Clegg ED. Semen quality and human fertility: a prospective study with healthy couples. J Androl. 2000;21:145–153.
    1. Slama R, Eustache F, Ducot B, et al. Time to pregnancy and semen parameters: a cross-sectional study among fertile couples from four European cities. Hum Reprod. 2002;17:503–515.
    1. Guzick DS, Overstreet JW, Factor-Litvak P, et al. Sperm morphology, motility, and concentration in fertile and infertile men. N Engl J Med. 2001;345:1388–1393.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit