The aim of our product SpermRun

SpermRun is a novel chip-based diagnostic product to test sperm quality for household use. Although sperm quality examinations are available in hospitals, a sense of embarrassment and the inconvenience of hospital appointments often hinder people from travelling to the hospital. Our product is tailored for men to self-conduct the test at home so that they can receive a preliminary result of their sperm quality status with convenience and accuracy.

According to our integrated human practice activities, in particular, during consultations with associate professor Lan Xie of Tsinghua University, we learned that current hospital examinations on sperm concentration and motility mainly depend on manual microscope observation, which is inefficient and strenuous. Moreover, under the influence of the COVID19 pandemic, hospital is less accessible, adding additional barriers for patients to receive a sperm quality examination in the hospital. At present, there are related products on the market that can perform household sperm motility test, but most of them only detect the concentration of sperm with incurrate and unreliable results. In contrast, our product can provide quick and accurate results on sperm concentration, motility and fertily simultaneously.

The most significant advantage of our product is that sperm motility and fertility can be examined simultaneously in one kit by detecting two biomarkers on the sperm surface representing these two indexes, namely Sp10 and EGFR. To be more specific, Sp10 indicates sperm motility, while EGFR indicates sperm fertility.

The detection is achieved within a microfluidic chip consisting of microchannels to manipulate the fluid and integrate signals from biological samples. By establishing a concentration gradient of chemokines in the channel of the chip, we can induce viable sperms to enter the detection area containing engineered bacteria to simulate the screening process of sperm motility in natural in vivo fertilization process. Microfluidic technology also promises that the detection of sperm motility and fertility could occur in one chip at the same time in a simple household device with relatively low cost.

Read more about our microfluidic chip design on Hardware page.

Market Analysis: SWOT

We applied SWOT strategy^[1] to analyze the internal and external factors that may influence the promotion of our product. In this way, we can possess an objective and comprehensive vision of our project.

User-friendly Instructions

Our product SpermRun is user-friendly. Just a drop of semen loaded onto the chip could reveal results of sperm quality within hours. Since our product is targeted at household use, the chip is designed to transform sperm quality into visualizable fluorescent signals. To achieve this goal, we first transformed the standard sperm motility index (sperms with speed greater than 5 um/s account for at least 32%), which is rather difficult to be directly measured, into a more visualizable signal that can be easily measured by engineered "bacteria referee" that can verify sperm motility as the number of sperms that have traveled across a certain distance in limited time periods.

The two protein signals representing motility and fertility respectively can be separated by triggering downstream expression of different reporter proteins. When Sp10 is detected, fluorescence signal of CFP can be seen under UV light, which is avaibale for some flashlights. In contrast, when EGFR is detected, fluorescence signal of mCherry can be seen under normal sunlight. Therefore, healty semen sample with strong motility and fertility would appear red under normal sunlight and show fluorescence signal under UV light. No professional operation skills and instruments are required. Everyone can use this chip for household detection. Even people with color-blindness or color-weakness issues can have no problem using our product since fluorescence signal under UV light does not depend on color sense. Besides, in case that some users in developing regions might have trouble reading, we include as many illustrations as possible in our instruction brochure.

One of our project targets is men of reproductive age. We start from the aging problem in China, yet increasing rate of male infertility and the influence of COVID19 pandemic are widespread across the world. Males worldwide are worried about the unsatisfactory quality of their sperms, and the early screening and prognosis in hospitals in other countries are more or less influenced by the pandemic as well. Therefore, our product can be applied and promoted worldwide. On the whole, what we are concerned about is the sustainable development of human being. Our project of rapid sperm quality test can provide a feasible way of self-examining the sperm quality at home with accuracy and convenience, contributing our efforts to takcling the issue of reproductive health.

This brings us to our next target group - community health care centers. Such institutions are going to benefit from the rapid test as it will be efficient and relatively low cost with accuracy and convenience. Currently, with increasing infertility rate among the population, the Chinese government is driving more and more community health service center to provide reproductive health services to community residents, which is huge policy bonus to us and creates opportunities to promote our products. We have been acquainted with this information from consultations with Yiqun Gu in Male Clinical Research Unit, in one of our integrated human practices activities.

Furthermore, hospitals with Center for Reproductive Medicine could also be our target group for two reasons. On the one hand, our product can be utilized by patients to self-conduct a preliminary examination to aid the current time-consuming and strenuous microscopic examination in hospitals by means of manual observation. With such preliminary results, doctors could decide whether further detailed examinations are needed. On the other hand, our product of rapid semen quality testing can contribute to high-throughput screening of high-quality semen in in vitro fertilization technology, promoting the field of assisted reproduction to improve its efficiency^[2].

Additionally, we should not forget that high reproductive rates are essential for animal raising. Apart from human reproductive health, by simply replacing the system components, we can also apply our product to monitor the semen quality of laboratory animals, which is of great significance on laboratory management.

In general, we hope to influence the field of human reproductive health and assist reproduction with our product, enhancing public awareness of the necessity and urgency of early screening of sperm quality.

Read more about our insights from societal perspective on our Integrated Human Practices page.

Our product includes genetically modified bacteria which measure the biomarkers on the sperm surface. In order to control the spread of this GMO organism, we would design our strain to be auxotroph so that they cannot live outside our device. If engineered bacteria escape the device and enters the environment, it would be inactivated.

There are some other considerations that need to be taken into account. Firstly, we need to measure the clinical significance of our product. Through the clinical trials, we will find out whether our product is effective and safe to use and whether the test is specific and sensitive enough to generate reliable results. For now, we can only assess whether engineered bacteria produce proper fluorescence signals when exposed to the biomarkers on the normal mouse sperm surface. Moreover, our product is composed of GMOs as it has some particular changes in the genome. This generates some legislative restrictions in China. Although the part of society is still keeping a distance from the products containing GMOs, hostility toward those products usage has dropped remarkably in the last decade, increasing the opportunities to successfully implement our designed product into the real-word.

[1] Teoli, D., Sanvictores, T., & An, J. (2021). SWOT Analysis. In StatPearls. StatPearls Publishing.
[2] Rappa, K. L., Rodriguez, H. F., Hakkarainen, G. C., Anchan, R. M., Mutter, G. L., & Asghar, W. (2016). Sperm processing for advanced reproductive technologies: Where are we today?. Biotechnology advances, 34(5), 578–587.
[3] Hadi, Hind & Ali, Rihab. (2021). WHO laboratory manual for the Examination and processing of human semen FIFTH EDITION.