Michailov Yulia, Amsalem Eden, Umanski Natalia, Tamadaev Valeria, Friedler Shevach, Saar-Ryss Bozhena
Ben Gurion University of the Negev, Faculty of Health Sciences, Beer Sheva, Israel.
IVF Unit-Obstetrics and Gynecology Department, Barzilai Medical Center, Ashkelon, Israel.
Reprod Biol Endocrinol. 2025 Jun 10;23(1):90. doi: 10.1186/s12958-025-01424-w.
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.
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.
The data suggest that the Q300™ significantly improved day-3 embryo development, blastulation, and cumulative pregnancy rates.
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.
NCT06232720. Date of registration: 15 February 2023. Enrollment of first subject: 20 August 2023. For more information, visit: https://clinicaltrials.gov/study/NCT06232720 .
不孕症影响着全球相当一部分人口，男性因素导致的不孕症几乎占所有病例的一半。体外受精（IVF）等辅助生殖技术（ART）的成功取决于选择具有最佳活力、形态和DNA完整性的高质量精子。Q300™ 设备提供了一种改进精子选择的新方法。利用先进的光学成像系统，Q300™ 分离出形态符合要求的精子细胞用于注射到卵母细胞中。本研究旨在评估Q300™ 设备在生育实验室环境中 “实际条件” 下的可用性和初步临床结果。
将从巴兹莱医疗中心收集的使用或未使用该技术的初步临床数据与根据维也纳共识制定的ART实验室关键绩效指标（KPI）进行比较。
数据表明，Q300™ 显著提高了第3天胚胎发育、囊胚形成率和累积妊娠率。
通过提供更精细、高效的选择过程，Q300™ 有可能重新定义不孕症治疗的临床实践，为患者提供更高的成功几率。
NCT06232720。注册日期：2023年2月15日。首例受试者入组日期：2023年8月20日。详情请访问：https://clinicaltrials.gov/study/NCT06232720 。
