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Infection detection in human semen

Periodic Reporting for period 1 - DetectInMen (Infection detection in human semen)

Periodo di rendicontazione: 2019-07-01 al 2019-12-31

Male infertility crises are observed in developed countries world-wide, with serious socio-economic implications. One possible reason is asymptotic anaerobe bacterial infection, which is only detectable by currently applied analytical methods after anaerobe sampling. This method, however, cannot be integrated to clinical practice. We developed a highly reliable bacterial infection detection method (DetectInMen) for human semen. Our method requires no cell culturing, can analyse samples without pre-conditioning, detects anaerobic bacteria species without anaerobic sampling and processing.
We carried out a feasibility study examining both technical feasibility and business viability of the project. We made preparation for clinical study. We made a clinical trial design, determined the gold standards and outlined ethical considerations for the clinical study. We selected some potential clinics. In addition, we validated our business assumptions by structured interviews with men’s fertility specialists (andrologists) and medical laboratory service providers. Furthermore, we performed a risk assessment and suggested mitigations for the risks. We have also completed our business plan based on business model canvas, including our company strategy, commercial model, financial scale-up plan, organisational growth plan. We also made an analysis on IP protection, regulatory issues and freedom to operate. Finally, we made a detailed plan for a further grant in the EIC-Accelerator Pilot including both grant and equity component.
The project is based on a ground-breaking innovation, since no current method can detect anaerobic bacterial infection in human semen by the applied clinical routine. Application of DetectInMen method will increase success of therapy for infertile and subfertile men: double the number of within-1-year successful fertility treatments, decreasing the number of unsuccessful therapies by 1/3. It may also reduce the need for assisted reproduction, decreasing the high costs for both the patient and health service. The success of this project will also impact on our company growth.