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超慢速冷冻 Slush 氮冷冻卵子的胚胎学结局与传统液氮相似:一项随机对照试验。

Embryology outcomes after oocyte vitrification with super-cooled slush nitrogen are similar to outcomes with conventional liquid nitrogen: a randomized controlled trial.

机构信息

Division of Reproductive Endocrinology and Infertility, Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey; Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.

Division of Reproductive Endocrinology and Infertility, Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey; Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.

出版信息

Fertil Steril. 2022 Jan;117(1):106-114. doi: 10.1016/j.fertnstert.2021.08.043. Epub 2021 Oct 13.

DOI:10.1016/j.fertnstert.2021.08.043
PMID:34654569
Abstract

OBJECTIVE

To determine whether the use of slush nitrogen (SN), a super-cooled form of nitrogen with a temperature from -207 to -210 °C, can improve oocyte survival after vitrification and warming compared with conventional liquid nitrogen (LN).

DESIGN

Randomized controlled trial.

SETTING

Academic-affiliated private practice.

PATIENT(S): A total of 556 metaphase II oocytes from 32 oocyte donor cycles were included.

INTERVENTION(S): Donor oocytes were block randomized to undergo vitrification with either SN or LN. Vitrification was followed by warming, fertilization with donor sperm, embryo culture to the blastocyst stage, and preimplantation genetic testing for aneuploidy via trophectoderm biopsy with targeted next-generation sequencing.

MAIN OUTCOME MEASURE(S): The primary outcome was oocyte survival after vitrification and warming. Secondary outcomes included rates of fertilization, usable blastocyst formation, and whole chromosome aneuploidy.

RESULT(S): Half of the metaphase II oocytes (n = 278) were randomized to undergo vitrification with SN, whereas the other half (n = 278) were randomized to undergo vitrification with LN. There were no statistically significant differences noted in oocyte survival rate (85.3% vs. 86.3%), fertilization rate (84.0% vs. 80.0%), rate of usable blastocyst formation (54.3% vs. 55.7%), or rate of whole chromosome aneuploidy (9.4% vs. 11.7%) between the SN and LN arms, respectively.

CONCLUSION(S): The implementation of an SN oocyte vitrification protocol resulted in similar embryology outcomes compared with LN. The use of SN did not lead to any demonstrable improvement in oocyte survival after vitrification and warming.

CLINICAL TRIAL REGISTRATION NUMBER

NCT04342364.

摘要

目的

确定超冷氮(SN)——温度在-207 至-210°C 之间的一种过冷氮形式——的使用是否能比传统液氮(LN)提高卵母细胞在玻璃化和复苏后的存活率。

设计

随机对照试验。

设置

学术附属的私人诊所。

患者

共纳入 32 个卵母细胞捐赠周期的 556 个中期 II 卵母细胞。

干预

将供体卵母细胞进行分组随机,分别进行 SN 或 LN 的玻璃化处理。玻璃化后进行复苏、与供体精子受精、胚胎培养至囊胚阶段,以及通过靶向下一代测序的滋养外胚层活检进行胚胎植入前遗传学检测以筛查非整倍体。

主要观察指标

主要观察指标是玻璃化和复苏后卵母细胞的存活率。次要观察指标包括受精率、可使用的囊胚形成率和全染色体非整倍体率。

结果

一半的中期 II 卵母细胞(n = 278)被随机分为 SN 玻璃化组,另一半(n = 278)被随机分为 LN 玻璃化组。SN 组和 LN 组的卵母细胞存活率(85.3% vs. 86.3%)、受精率(84.0% vs. 80.0%)、可使用囊胚形成率(54.3% vs. 55.7%)或全染色体非整倍体率(9.4% vs. 11.7%)均无统计学差异。

结论

实施 SN 卵母细胞玻璃化方案与 LN 相比,具有相似的胚胎学结局。使用 SN 并未导致玻璃化和复苏后卵母细胞存活率有任何明显提高。

临床试验注册号

NCT04342364。

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