Purpose

The main purpose and research question of the study are to compare the efficacy of high-security closed versus open devices for human oocytes’ vitrification.

Methods

A prospective randomized study was conducted. A total of 737 patients attending the Infertility and IVF Unit at S.Orsola University Hospital (Italy) between October 2015 and April 2020 were randomly assigned to two groups. A total of 368 patients were assigned to group 1 (High-Security Vitrification™ - HSV) and 369 to group 2 (Cryotop® open system). Oocyte survival, fertilization, cleavage, pregnancy, implantation, and miscarriage rate were compared between the two groups.

Results

No statistically significant differences were observed on survival rate (70.3% vs. 73.3%), fertilization rate (70.8% vs. 74.9%), cleavage rate (90.6% vs. 90.3%), pregnancy/transfer ratio (32.0% vs. 31.8%), implantation rate (19.7% vs. 19.9%), nor miscarriage rates (22.1% vs. 21.5%) between the two groups. Women’s mean age in group 1 (36.18 ± 3.92) and group 2 (35.88 ± 3.88) was not significantly different (P = .297). A total of 4029 oocytes were vitrified (1980 and 2049 in groups 1 and 2 respectively). A total of 2564 were warmed (1469 and 1095 in groups 1 and 2 respectively). A total of 1386 morphologically eligible oocytes were inseminated by intracytoplasmic sperm injection (792 and 594 respectively, P = .304).

Conclusions

The present study shows that the replacement of the open vitrification system by a closed one has no impact on in vitro and in vivo survival, development, pregnancy and implantation rate. Furthermore, to ensure safety, especially during the current COVID-19 pandemic, the use of the closed device eliminates the potential samples’ contamination during vitrification and storage.

中文翻译：

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高安全性封闭设备可高效、安全地保护人类卵母细胞在玻璃化和储存过程中免受病毒污染的潜在风险，特别是在 COVID-19 大流行期间

目的

该研究的主要目的和研究问题是比较高安全性封闭式与开放式人类卵母细胞玻璃化冷冻装置的功效。

方法

进行了一项前瞻性随机研究。2015 年 10 月至 2020 年 4 月期间，共有 737 名在 S.Orsola 大学医院（意大利）不孕不育和试管受精科就诊的患者被随机分为两组。共有 368 名患者被分配到第 1 组（高安全性玻璃化™ - HSV），369 名患者被分配到第 2 组（Cryotop® 开放系统）。比较两组的卵母细胞存活率、受精率、卵裂率、妊娠率、着床率和流产率。

结果

存活率（70.3% vs. 73.3%）、受精率（70.8% vs. 74.9%）、卵裂率（90.6% vs. 90.3%）、妊娠/移植率（32.0% vs. 31.8）没有观察到统计学上的显着差异。 %）、着床率（19.7% vs. 19.9%）和流产率（22.1% vs. 21.5%）两组之间也没有差异。第 1 组 (36.18 ± 3.92) 和第 2 组 (35.88 ± 3.88) 中女性的平均年龄没有显着差异 ( P = .297)。总共 4029 个卵母细胞被玻璃化冷冻（第 1 组和第 2 组分别为 1980 个和 2049 个）。共有 2564 人被加热（第 1 组和第 2 组分别为 1469 人和 1095 人）。通过胞浆内单精子注射对总共 1386 个形态合格的卵母细胞进行了授精（分别为 792 和 594，P = .304）。

结论

本研究表明，用封闭式玻璃化冷冻系统替代开放式玻璃化冷冻系统对体外和体内的存活、发育、妊娠和着床率没有影响。此外，为了确保安全，特别是在当前的COVID-19大流行期间，封闭设备的使用消除了玻璃化和储存过程中潜在的样品污染。