Department of OB/GYN/Women's Health Institute, Cleveland Clinic Fertility Center, Beachwood, OH, USA.
Reprod Biol Endocrinol. 2013 May 15;11:41. doi: 10.1186/1477-7827-11-41.
The Rapid-i is a new FDA cleared closed carrier for embryo vitrification. The cooling rate of - 1220°C/min is far lower than that reported with open vitrification systems such as the cryoloop (-15,000°C/min). Little published data is currently available on this device. This study presents our initial clinical data, as well as live birth outcomes, with the Rapid-i. The efficacy of this device for the cryopreservation of cleavage, as well as blastocyst stage human embryos is also analyzed. We further compare outcomes to those achieved with the cryoloop, an "open" vitrification system routinely used in our laboratory.
Human embryos were vitrified at either the 8-10 cell stage or else the blastocyst stage. The vitrification protocol was: 7.5% DMSO/7.5% ethylene glycol (EG) (2-3 min) followed by incubation in 15% DMSO /15% EG (45 sec) before loading on the vitrification carrier. Cryoprotectant was removed during warming by sequential washes in 0.25 M and 0.125 M sucrose in culture medium. Clinical outcome data for frozen cycles between January 2011 and August 2012 were stratified according to carrier and cell stage. The student t-test and chi square test were used to compare results. P value of < 0.05 was considered significant.
A total of 486 vitrified-warmed embryos were assessed and 92% of them were transferred. The clinical pregnancy rate (CPR) and implantation rate (IR) with Rapid-i vitrified blastocysts were 59% and 49%, versus 47% and 37%, respectively for cleavage stage embryos. This was not statistically different from results with the cryoloop vitrified blastocysts (CPR 46%, IR 38%) nor the cleavage stage vitrified embryos (CPR 49%, IR 35%). To date, there have been 31 deliveries of 34 healthy infants from Rapid-i vitrified embryos, with another 12 pregnancies still on-going.
The Rapid-i offers an excellent alternative to existing open vitrification devices for embryo cryopreservation at the 8-10 cell stage as well as the blastocyst stage. Use of this type of "closed" sealed system that prevents direct contact between the embryos and liquid nitrogen reduces the potential risk of sample cross-contamination or infection. These preliminary data and live birth outcomes have paved the way toward transitioning to a closed vitrification system in our own IVF program.
Rapid-i 是一种新的经美国食品和药物管理局（FDA）批准的胚胎玻璃化冷冻封闭载体。其冷却速度为-1220°C/min，远低于 cryoloop 等开放式玻璃化系统的报告速度（-15,000°C/min）。目前关于该设备的数据很少。本研究介绍了我们使用 Rapid-i 的初步临床数据以及活产结局。还分析了该设备在冷冻 8-10 细胞期和囊胚期人类胚胎方面的功效。我们进一步将结果与我们实验室常规使用的开放式玻璃化系统 cryoloop 进行比较。
将人类胚胎在 8-10 细胞期或囊胚期进行玻璃化冷冻。玻璃化冷冻方案为：7.5% DMSO/7.5% 乙二醇（EG）（2-3 分钟），然后在 15% DMSO/15% EG（45 秒）中孵育，然后在玻璃化载体上加载。在解冻过程中，通过在培养基中用 0.25 M 和 0.125 M 蔗糖进行连续洗涤来去除保护剂。2011 年 1 月至 2012 年 8 月冷冻周期的临床结局数据根据载体和细胞阶段进行分层。使用学生 t 检验和卡方检验比较结果。P 值<0.05 被认为具有统计学意义。
共评估了 486 个玻璃化冷冻-解冻胚胎，其中 92%进行了移植。使用 Rapid-i 玻璃化冷冻囊胚的临床妊娠率（CPR）和植入率（IR）分别为 59%和 49%，而 8-10 细胞期胚胎分别为 47%和 37%。与 cryoloop 玻璃化冷冻囊胚（CPR 46%，IR 38%）和 8-10 细胞期玻璃化冷冻胚胎（CPR 49%，IR 35%）相比，这无统计学差异。迄今为止，已有 31 名来自 Rapid-i 玻璃化冷冻胚胎的健康婴儿分娩，另有 12 名孕妇仍在妊娠中。
Rapid-i 为 8-10 细胞期和囊胚期胚胎的玻璃化冷冻提供了一种优于现有开放式玻璃化设备的绝佳替代方案。使用这种“封闭”密封系统可防止胚胎与液氮直接接触，降低了样本交叉污染或感染的潜在风险。这些初步数据和活产结局为我们在自己的体外受精（IVF）项目中过渡到封闭玻璃化系统铺平了道路。
Zotero 插件
