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Abstract Study question How does the Q300™ Device impact clinical outcomes in a reproductive laboratory environment compared to established standards? Summary answer The device showed favorable clinical outcomes and was user-friendly. More research is needed to identify the patient subgroups that can benefit the most from system What is known already Embryologists struggle with accurately assessing sperm morphology without staining, prompting interest in emerging technologies like AI. These methods evaluate motility parameters, offering non-invasive sperm selection. A previous study comparing Q300 to manual staining methods showed high agreement and repeatability, indicating Q300’s accuracy in measuring live sperm cells. It aids in selecting cells per WHO2021 guidelines without staining, potentially revolutionizing sperm assessment. Study design, size, duration The study is an open-label, non-randomized study. Semen samples intended for ICSI were imaged by the Q300™ device before micro-injection to aid in selecting morphologically compliant sperm cells. The data collected was compared to the Key Performance Indicators (KPI) for ART laboratories according to the Vienna Consensus. Up to 5 sites will be enrolled in the study, with up to 100 couples in total from all sites. Study duration: 18 months Participants/materials, setting, methods The Q300™ device is an optical system using quantitative phase microscopy and holographic imaging to analyze human semen morphology. The device aids embryologists in selecting live and motile sperm cells for ICSI by providing automatic, objective analysis. Couples meeting inclusion criteria, including female age ≤40 and availability of motile sperm, were recruited for ICSI procedures. There were no restrictions on previous IVF/ICSI cycles. Endpoints: fertilization, day-3 embryo development, good blastocyst development rates, and implantation rates. Main results and the role of chance 14 couples were recruited from Barzilay Medical Center’s IVF unit in Ashkelon, Israel. The average fertilization rate is 79.1% (Vienna consensus competency is ≥ 65%), the day 3 embryo development rate is 55% (Vienna consensus competency is ≥ 45%), and the good blastocyst development rate is 42.5% (Vienna consensus competency is ≥ 30%). The implantation rate (day 3+day5) is 36.8% (Vienna consensus competency is ≥ 25% for day 3 embryo transfers and ≥ 35% for blastocyst transfers). The intended users performed the procedures with no reported malfunctions. 270 sperm imaging procedures were performed using the Q300 device to select 109 morphologically suitable cells for ICSI. The utilization of the product resulted in approximately a 40% yield of correct selections by the embryologist. Consequently, out of every 10 cells deemed compliant by the embryologist, only 4 were confirmed by the device, with roughly 3 falling within a margin of 10% around the WHO measurement range. Moreover, only about 1 of these selections fell within the boundaries defined by the WHO standards. This observation offers insights into the characteristics of cells routinely chosen for injection into oocytes. Limitations, reasons for caution The study recruited 14 couples from a single site; it is important to validate and statistically power the outcome measures and compare them with clinical control groups in the future. In the next generation of the product, incorporating an objective selection based on sperm motility can further improve its functionality. Wider implications of the findings The findings offer insights into optimizing sperm selection processes, potentially improving fertilization, embryo development, and implantation rates in couples undergoing ICSI. Moreover, the study highlights the importance of continued research and refinement of technological innovations in ART to better serve patient needs and improve treatment outcomes. Trial registration number NCT06232720
Michailov et al. (Mon,) studied this question.