Clinical Update on Home Testing for Male Fertility

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Clinical Update on Home Testing for Male Fertility
Daniel Gonzalez, Manish Narasimman, Jordan C. Best, Jesse Ory, Ranjith Ramasamy


Male factor infertility accounts for about 50% of the incidence of infertility in couples. In current practice, the men must attend a clinic or hospital facility to provide a semen analysis, which is key to the diagnosis of the male reproductive potential. However, many men are often embarrassed with the process and conventional semen analysis requires complex, labor-intensive inspection with a microscope. To mitigate these problems, one of the solutions can be at-home semen analysis. In this review, we examine the literature of currently available at-home semen analysis test kits, describe their limitations, and compare them to the conventional lab-based methods.


INTRODUCTION


Infertility has been a consistent problem that currently still affects approximately 10% to 20% of reproductive-aged couples worldwide [1-3]. Male factor has been found to be responsible for an estimated 40% to 50% of all infertility cases. Male factor infertility is often attributed to poor semen quality with suboptimal sperm motility, limited concentration, or abnormal morphology [1,2,4]. Through evaluation and subsequent treatment, reversible causes of male factor infertility may be determined, which can present a more cost-effective treatment option for couples than immediately employing assisted reproductive technology [4]. Standard semen analysis, in accordance with World Health Organization (WHO) criteria, is commonly done to evaluate the semen parameters in order to assess the male fertility potential. However, standard semen analysis is complex, laborious, time-consuming, and can even be stressful for many patients due to the cost as well as feelings of embarrassment, which may prevent them from seeking medical attention for infertility [5-10]. Conversely, at-home semen analysis kits can alleviate financial burden and allay concerns with privacy and embarrassment while providing a valuable diagnostic tool for patients who may suffer from male factor infertility that is more convenient than conventional semen analysis.

Regarding the collection of the semen sample, studies have either found no difference between semen parameters in samples collected at home versus in the clinical setting or an improvement in semen quality for samples collected at home, indicating a potential benefit of at-home assays for infertility investigation. Moreover, reported satisfaction levels of at-home semen collection were higher, and this would be the method relied upon with at-home kits [11-13]. In a retrospective study of post-vasectomy semen analysis compliance, patients reported distance, time commitment, and forgetfulness as primary barriers to completing their semen testing and 92% of the 503 patients indicated home-based semen analysis would increase their compliance [14]. Furthermore, ease of use for laypeople of home semen analysis kits such as the Trak system has been demonstrated, while other methods of testing incorporate smartphones which can increase accessibility for patients [15-18]. Convenience, lower cost, and avoidance of potential social stigma and embarrassment make at home semen assays a broadly appealing option for investigating infertility. Herein, we recognize and acknowledge this review is similar to a review performed by Yu et al [5] and Kobori [6], but what differentiates this review is we provided insight into the principle interplaying within each respective kit, whether the kit gained US Food and Drug Administration (FDA) credibility, as well as discuss the limitations according to WHO criteria.



1. Standard semen analysis



DEVICES FOR HOME BASED SEMEN ANALYSIS

1. SpermCheck Fertility
2. Trak
3. SwimCount Sperm Quality test and FertilitySCORE
4. Smartphone-based at-home semen analysis: Men’s Loupe, SEEM, and YO clip



LIMITATIONS

In their current iterations, home-based semen analysis devices cannot be regarded as a complete replacement of the standard semen analysis conducted in a laboratory setting, and certainly not a substitute for consultation with a fertility specialist. While the at-home semen assay kits we reviewed displayed a high level of accuracy with an affordable price, they only tested sperm concentration or motility. Sperm morphology and other important parameters impacting potential fertility are not tested. Thus, at home assays should not be recommended as the sole test for male factor infertility in couples seeking pregnancy.
However, these kits can still be effectively used to detect possible seminal defects early on instead of spending extensive time waiting for natural pregnancy to occur [32]. In this regard, home-based semen analysis kits can serve the role of an indicator to pursue additional evaluation or fertility assistance for patients who do present with suboptimal sperm concentration or motility according to the home test. It should also be emphasized to consumers of these products the potential of false-negative results and that additional testing in a clinic may still be necessary. Home-based semen analysis may have the greatest benefit for post-vasectomy patients where sperm count is of the most importance, through the option to test at home increasing compliance because of its convenience [14].



CONCLUSIONS

At-home semen analysis kits provide a rapid, cost-effective tool for evaluating fertility potential in couples seeking pregnancy that may be affected by male factor infertility.
While the social stigma of seeking fertility treatment may not be as prevalent as it once was, home-based semen analysis still provides the privacy, convenience, and lower cost that are greatly appealing to men who may be unwilling to otherwise seek clinical evaluation. Technological advancements have allowed at-home semen analysis kits to be accurate and relatively easy to use for the typical patient. While a significant shortcoming of the at-home kits is their inability to assess all semen parameters that may contribute to infertility, they are still valuable in their capacity to test sperm concentration and motility, encourage further testing and provide a convenient first step for men reluctant to evaluate their fertility clinically.
 

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madman

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Fig. 1. SpermCheck Fertility device and results. The device is shown before a sample has been added. Following a 20 minute semen liquefaction period, 100 μL of semen is sampled and mixed with a detergent that solubilizes the sperm’s acrosomal membranes, releasing SP-10 protein. Four drops of the solution are applied to the sample well (1). Colloidal gold-conjugated monoclonal SP-10 antibodies present on the absorbent pad bind to the solubilized SP-10 antigen (2). The solution migrates along the nitrocellulose strips by capillary action. At test line (T), a second monoclonal antibody captures the gold-antibody-SP-10 complex, resulting in the appearance of a red line at this position (3). The appearance of lines at the control position indicates the device functioned properly. Diagnostic devices showing a concentration of over 20 million (A-C), below 20 million (D), and a type of invalid test result (E). The presence of red control line must appear to ensure the result is valid and test fluid has completely flowed over the test line, which must appear within the 7-minute assay period.
Screenshot (2930).png

Screenshot (2931).png
 

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Fig. 2. (A) Trak Male Fertility Testing system components and operation. The system contents include a reusable engine, single-use test cartridges (Props), fluid transfer device, liquefaction cups. The photo shows a prop placed on the engine. To operate the system, the user collects a semen sample in an enzyme-coated collection cup that promotes liquefaction. Then, the user transfers 0.25 mL of semen to the Prop inlet chamber, attaches the Prop to the engine, and closes the lid to initiate the spin sequence, which runs for 6 minutes at 7,000 rpm. When the spin sequence is complete, the sperm cells form a visible, measurable white column that’s proportional to the concentration of sperm. (B) Test results of samples with low (<15 million/mL), moderate (15–55 million/mL), and optimal (>55 million/mL) sperm concentrations.
Screenshot (2932).png
 

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Fig. 3. Principles SwimCount and FertilitySCORE device and results of SwimCount shown in the results window. (A) Total progressively motile sperm concentration (PMSC). The device is composed of two macro-chambers, which are separated by a filter with a pore of 10 μm. Only progressively motile spermatozoa, with normal morphology, pass through this filter once the device is activated. A total of 30 minutes is required for complete dyeing of spermatozoa, utilizing a solution consisting of phosphate-buffered saline and 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide on top of the filter. (B) Example test results that show less than 5 million/mL, between 5–20 million/mL, and more than 20 million/mL total PMSC. (C) FertilitySCORE is based on the principle of metabolically active spermatozoa chemically change the structure of a Resazuin color dye from dark blue to pink and diagnosis whether the motile sperm concentration is 20 million sperm/mL or above.
Screenshot (2935).png

Screenshot (2936).png
 

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Fig. 4. Men’s Loupe (Tenga Health Care) device and smartphone-based SEEM kit. (A) Men’s Loupe 0.8 mm diameter ball lens microscope attached to a smartphone. (B) The technique for loading semen sample into a plastic jacket of ball lens microscope. (C) Magnifying lens semen analysis device with QR code sheet to download the application for operating. (D) Instructions of kit for use. (E) Screenshot of sample test results with concentration and motility.
Screenshot (2937).png
 

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Fig. 5. The YO Home Sperm test device and components. (A) YO kit contents, including, (A-a) collection cup, (A-b) liquefaction powder, (A-c) fixed coverslip slide (d) fixed volume transfer pipettes, and (A-e) YO testing clip. (B) The assembled YO clip with inserted testing slide. (C) Sample as seen on the phone screen.
Screenshot (2938).png




Table 2. YO score based on motile sperm concentration
Screenshot (2939).png
 

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Fig. 6. The ExSeed Home Sperm test device and components. (A) ExSeed kit contents, including, (A-a) collection cup & transfer pipette, (A-b) ExSeed testing clip, and (A-c) fixed coverslip slide.
Screenshot (2940).png

Screenshot (2942).png
 
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