Clinical Outcome Using the Q300™ Device in a Reproductive Laboratory Environment: an open-label, non-controlled and non-randomized study

Background Infertility affects a significant portion of the global population, with male factor infertility contributing to nearly half of all cases. The success of assisted reproductive technologies (ART), such as in vitro fertilization (IVF), depends on selecting high-quality sperm with optimal motility, morphology, and DNA integrity. The Q300™ device for sperm selection offers a revolutionary approach to enhancing these parameters. Utilizing an advanced optical imaging system, the Q300™ isolates the morphologically compliant sperm cells sperm for injection into the oocytes. This study aims to assess the usability and preliminary clinical outcome of the Q300™ device under "real-life conditions" in a fertility laboratory setting. Methods Preliminary clinical data collected from Barzilai Medical Center with or without using the technology was compared to the Key Performance Indicators (KPI) for ART laboratories according to the Vienna Consensus. Results The data suggests that the Q300™ significantly improved day-3 embryo development, blastulation, and cumulative pregnancy rates. Conclusions By offering a more refined and efficient selection process, the Q300™ has the potential to redefine clinical practice in infertility treatment, providing patients with a higher likelihood of achieving successful outcomes. Trial registration: NCT06232720 https://clinicaltrials.gov/study/NCT06232720. Date of registration: 15 Feb 2023. Date of enrollment of first subject: 20 August 2023.