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微流控精子处理对与密度梯度离心相比囊胚整倍体率的影响:一项姐妹卵母细胞双盲前瞻性随机临床试验。

The impact of microfluidics sperm processing on blastocyst euploidy rates compared with density gradient centrifugation: a sibling oocyte double-blinded prospective randomized clinical trial.

机构信息

The Center for Advanced Reproductive Services, Farmington, Connecticut; Division of Reproductive Endocrinology and Infertility, University of Connecticut School of Medicine, Farmington, Connecticut.

The Center for Advanced Reproductive Services, Farmington, Connecticut.

出版信息

Fertil Steril. 2024 Jul;122(1):85-94. doi: 10.1016/j.fertnstert.2024.02.021. Epub 2024 Feb 15.

DOI:10.1016/j.fertnstert.2024.02.021
PMID:38367686
Abstract

OBJECTIVE

To compare the euploidy rates among blastocysts created from sibling oocytes injected with sperm and processed using microfluidics or density gradient centrifugation.

DESIGN

Sibling oocyte randomized controlled trial.

SETTING

Single university-affiliated infertility practice.

PATIENTS

A total of 106 patients aged 18-42 years undergoing fresh in vitro fertilization treatment cycles with preimplantation genetic testing between January 2021 and April 2022 contributed 1,442 mature oocytes, which were injected with sperm and processed using microfluidics or density gradient centrifugation.

INTERVENTION(S): The sperm sample is divided and processed using a microfluidics device and density gradient centrifugation for injection into sibling oocytes.

MAIN OUTCOME MEASURE(S): The primary outcome was the embryo euploidy rate. Secondary outcomes included fertilization, high-quality blastulation, and ongoing pregnancy rates.

RESULT(S): The blastocyst euploidy rate per mature oocyte was not significantly different in the study group compared with the control group (22.9% vs. 20.5%). The blastocyst euploidy rate per biopsied embryo was also similar between the 2 groups (53.0% vs. 45.7%). However, the fertilization rate per mature oocyte injected was found to be significantly higher in the study group compared with the control group (76.0% vs. 69.9%). The high-quality blastulation rate per mature oocyte injected was similar between the 2 groups, as was the total number of embryos frozen. There were no differences in the number of participants with no blastocysts for biopsy or the number of participants with no euploid embryos between the 2 groups. Among the male factor infertility and recurrent pregnancy loss subgroups, there were no differences in euploidy rates, fertilization rates, blastulation rates, or total numbers of blastocysts frozen, although the study was underpowered to detect these differences. Seventy-seven patients underwent frozen embryo transfer; there were no significant differences in pregnancy outcomes between the 2 groups.

CONCLUSION(S): Microfluidics processing did not improve embryo euploidy rates compared with density gradient centrifugation in this sibling oocyte study, although fertilization rates were significantly higher.

CLINICAL TRIAL REGISTRATION NUMBER

NCT04744025.

摘要

目的

比较经精子注射和微流控或密度梯度离心处理的同卵卵母细胞所形成的囊胚的整倍体率。

设计

同卵卵母细胞随机对照试验。

地点

单所大学附属不孕诊所。

患者

2021 年 1 月至 2022 年 4 月期间进行新鲜体外受精治疗周期并进行植入前遗传学检测的 106 名年龄在 18-42 岁的患者共贡献了 1442 个成熟卵母细胞,这些卵母细胞经精子注射并使用微流控或密度梯度离心进行处理。

干预

将精子样本进行分割并使用微流控装置和密度梯度离心进行处理,然后注入同卵卵母细胞。

主要观察指标

主要结局为胚胎整倍体率。次要结局包括受精率、优质囊胚形成率和持续妊娠率。

结果

与对照组相比,研究组每枚成熟卵母细胞形成的囊胚整倍体率无显著差异(22.9%比 20.5%)。两组每枚活检胚胎的囊胚整倍体率也相似(53.0%比 45.7%)。然而,与对照组相比,研究组每枚成熟卵母细胞注射的受精率显著更高(76.0%比 69.9%)。两组每枚成熟卵母细胞注射的优质囊胚形成率相似,冷冻胚胎总数也相似。两组间活检无囊胚的参与者人数和无整倍体胚胎的参与者人数均无差异。在男性因素不孕和复发性妊娠丢失亚组中,两组间的整倍体率、受精率、囊胚形成率或冷冻的囊胚总数均无差异,尽管该研究的效力不足以检测到这些差异。77 名患者接受了冷冻胚胎移植;两组间的妊娠结局无显著差异。

结论

在这项同卵卵母细胞研究中,与密度梯度离心相比,微流控处理并未提高胚胎整倍体率,尽管受精率显著更高。

临床试验注册号

NCT04744025。

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