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Modified MicroSecure Vitrification: A Safe Simple and Highly Effective Cryopreservation Procedure for Human Blastocysts

机译:修改过的MicroSecure玻璃化:一种安全简单高效的人类胚泡冷冻保存程序。

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摘要

Clinical embryo vitrification evolved with the development of unique vitrification devices in the 21st century and with the misconception that ultra-rapid cooling in an "open" system (i.e., direct LN2 contact) was a necessity to optimize vitrification success. The dogma surrounding the importance of cooling rates led to unsafe practices subject to technical variation and to the creation of vitrification devices that disregarded important quality-control factors (e.g., ease of use, repeatability, reliability, labeling security, and storage safety). Understanding the quality-control flaws of other devices allowed for the development of a safe, secure, repeatable, and reliable µS-VTF method aimed to minimize intra- and inter-technician variation. Equally important, it combined the availability of two existing FDA-compliant devices: 1) a 0.3-mL ionomeric resin embryo straw with internalized, dual-colored, tamper-proof labeling with repeatable weld seal potential; and 2) shortened, commonly-used, 300-µm ID sterile flexipettes to directly load the embryo(s) in order to create a highly-effective global vitrification device. Like other aseptic, closed vitrification systems (e.g., High Security Vitrification (HSV), Rapid-i, and VitriSafe) effectively used in reproductive medicine, microSecure Vitrification (µS-VTF) has proven that it can achieve high post-warming survival and pregnancy outcomes with its attention to simplicity, and reduced technical variation. Although the 0.3-mL embryo straw containing an internal hydrophobic plug was commercially replaced with a standard semen straw possessing cotton-polyvinyl pyrrolidone (PVP) plugs, it maintained its ionomeric resin composition to ensure weld sealing. However, the cotton plugs can wick out the fluid-embryo contents of the flexipettes upon contact. A modified µS-VTF method was adapted to include an additional internal weld seal before the plug on the device loading side. The added technical step to the µS-VTF procedure has not affected its successful application, as high survival rates (> 95%) and pregnancy rates continue today.
机译:随着21世纪独特的玻璃化装置的发展以及对“开放”系统(即直接接触LN2)的超快速冷却是优化的必要性的误解,临床胚胎玻璃化得到了发展。玻璃化成功。围绕冷却速度重要性的教条导致了不安全的做法,该做法受技术变化的影响,并导致制造了玻璃化设备,而忽略了重要的质量控制因素(例如,易用性,可重复性,可靠性,标签安全性和存储安全性)。了解其他设备的质量控制缺陷后,便可以开发出一种安全,可靠,可重复且可靠的µS-VTF方法,以最大程度地减少技术人员之间和技术人员之间的差异。同样重要的是,它结合了两个现有的符合FDA标准的设备的可用性:1)0.3-mL离聚物树脂胚芽吸管,带有可重复焊接密封潜力的内在,双色,防篡改标签; 2)缩短的,通常使用的300 µm内径无菌挠性滤光片,可以直接加载胚胎,从而创建高效的全玻璃化装置。像在生殖医学中有效使用的其他无菌封闭式玻璃化系统(例如,高安全性玻璃化(HSV),Rapid-i和VitriSafe)一样,microSecure玻璃化(µS-VTF)已证明可以实现较高的加温后存活率和妊娠率注重简单性,减少技术变化。尽管将含有内部疏水塞的0.3 mL胚胎吸管在商业上替换为具有棉-聚乙烯吡咯烷酮(PVP)塞的标准精液吸管,但它仍保持其离聚物树脂成分以确保焊接密封。但是,棉塞在接触时会芯吸出流形胶的液状内含物。修改后的µS-VTF方法适用于在设备加载侧的塞子之前添加一个额外的内部焊接密封。 µS-VTF程序增加的技术步骤并未影响其成功应用,因为高存活率(> 95%)和怀孕率一直持续到今天。

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