Clinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study.

Abstract

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 offers a novel approach for improving sperm selection. 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 were compared to the Key Performance Indicators (KPI) for ART laboratories according to the Vienna Consensus.

Results: The data suggest 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. Date of registration: 15 February 2023. Enrollment of first subject: 20 August 2023. For more information, visit: https://clinicaltrials.gov/study/NCT06232720 .