New test for anaerobic bacterial infection in men helps reduce infertility
According to the WHO, infertility is a growing global health issue partly because the prevalence of semen considered ‘normal’, known as normozoospermia, has been continuously declining. It is estimated that reduced male fertility is responsible for at least 40 % of infertility in couples globally. Sometimes, reduced fertility has a detectable cause. Often, it remains unexplained, attributed to environmental pollution, increased stress, sleeping problems or lifestyle factors. However, 30-40 % of cases are estimated to be caused by asymptotic infections. The EU-supported DetectInMen project is developing a test to detect the most relevant bacteria implicated in male reproductive organ infection, causing infertility. EU funding enabled the project to conduct a technical feasibility study and to further develop their business plan after interviewing men’s fertility specialists and medical laboratory service providers. They were also able to further prepare for clinical studies. To date, the team have one patent application pending for their bacteria identification method.
Bacteria detection without anaerobic sampling
Male fertility is usually detected by microscopic analysis of semen samples. These sometimes include bacteriological examination when symptoms of infection are observed. If the examination throws up a positive result, the standard practice is for traditional culturing in air, which can detect aerobic bacteria only. However, male reproduction organ bacterial infections are mostly caused by anaerobic bacterium species, often without identifiable symptoms. Anaerobic-specific sampling is difficult in current clinical practice, as samples are mostly collected after masturbation, when the semen is in contact with air. The DetectInMen method is based on the identification of phospholipids as ‘bacterial fingerprints’. These chemical compounds, found on the outer surface of the bacterium cell in high concentration, remain stable even after the bacterium cell is dead, as is the case with anaerobic bacterial strains after exposure to air. DetectInMen uses a spectrometer to generate the tell-tale signals necessary for the artificial intelligence (AI) based software tool to then analyse for the fingerprints of certain bacterium strains. “Our method can be easily integrated into current clinical practice. Lab technicians can use the DetectInMen tools to examine samples, without special sampling or processing. It can even be applied to frozen samples. It also detects several types of infections at once, without culturing, such as: bacterial; fungal; some viral, as well as anaerobic bacteria species,” says Eszter Varga, CEO of the biotechnology company, Fabtech, that hosted the project. If bacterial infection is detected, patients can receive targeted antibiotic treatment, with sperm quality improvement observed from about 3 months afterwards. As current detection methods often miss anaerobic bacterial infection, without a system like DetectInMen andrologists would usually not know to prescribe antibiotics, or how to select the appropriate ones or assess treatment.
Private and public benefit
Clinical adoption of the DetectInMen method could increase the success of treatment for infertile and subfertile men. This would reduce the time needed to achieve pregnancy, decreasing the number and cost of unsuccessful therapeutic attempts, and so also stress for couples. The next step will be to carry out clinical studies and obtain in vitro diagnostic (IVD) device classification. In the meantime, the team are working to standardise measurement protocols, include more bacteria strains and develop a strategy to conform to regulations (both European with CE marking and in the United States for FDA approval). To achieve this, they are currently seeking further grants and/or investment. Commercialisation will first target the private sector such as medical centres and clinical laboratory service providers, before expanding into the public healthcare sector.
Keywords
DetectInMen, semen, sperm, bacteria, infection, anaerobic, aerobic, infertility, phospholipids, antibiotics
