微流控法制备精子用于 ICSI 可产生与密度梯度离心法相似的胚胎质量：一项实用的、随机对照试验。

Microfluidic preparation of spermatozoa for ICSI produces similar embryo quality to density-gradient centrifugation: a pragmatic, randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, University of Southern California, Los Angeles, CA, USA.

Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.

出版信息

Hum Reprod. 2022 Jun 30;37(7):1406-1413. doi: 10.1093/humrep/deac099.

DOI:10.1093/humrep/deac099

PMID:35522187

Abstract

STUDY QUESTION

Does processing of spermatozoa for IVF with ICSI by a microfluidic sperm separation device improve embryo quality compared with density-gradient centrifugation?

SUMMARY ANSWER

Patients randomized to microfluidic sperm preparation had similar cleavage- and blastocyst-stage embryo quality and clinical and ongoing pregnancy rates to those who underwent standard sperm processing for IVF with ICSI.

WHAT IS KNOWN ALREADY

Microfluidic sperm preparation can isolate spermatozoa for clinical use with minimal DNA fragmentation but with unclear impact on clinical outcomes.

STUDY DESIGN, SIZE, DURATION: A prospective randomized controlled trial of 386 patients planning IVF from June 2017 through September 2021 was carried out.

PARTICIPANTS/MATERIALS, SETTING, METHODS: One hundred and ninety-two patients were allocated to sperm processing with a microfluidic sperm separation device for ICSI, while 194 patients were allocated to clinical standard density-gradient centrifugation (control) at an academic medical centre.

MAIN RESULTS AND THE ROLE OF CHANCE

In an intention to treat analysis, there were no differences in high-quality cleavage-stage embryo fraction [66.0 (25.8)% control versus 68.0 (30.3) microfluidic sperm preparation, P = 0.541, absolute difference -2.0, 95% CI (-8.5, 4.5)], or high-quality blastocyst fraction [37.4 (25.4) control versus 37.4 (26.2) microfluidic sperm preparation, P = 0.985, absolute difference -0.6 95% CI (-6, 5.9)] between groups. There were no differences in the clinical pregnancy or ongoing pregnancy rates between groups.

LIMITATIONS, REASONS FOR CAUTION: The population studied was inclusive and did not attempt to isolate male factor infertility cases or patients with a history of elevated sperm DNA fragmentation.

WIDER IMPLICATIONS OF THE FINDINGS

Microfluidic sperm separation performs similarly to density-gradient centrifugation in sperm preparation for IVF in an unselected population.

STUDY FUNDING/COMPETING INTEREST(S): No external funding to declare. M.P.R. is a member of the Clinical Advisory Board for ZyMōt® Fertility, Inc.

TRIAL REGISTRATION NUMBER

NCT03085433.

TRIAL REGISTRATION DATE

21 March 2017.

DATE OF FIRST PATIENT’S ENROLLMENT: 16 June 2017.

摘要

研究问题

与密度梯度离心法相比，使用微流控精子分离装置处理用于 IVF-ICSI 的精子是否会提高胚胎质量？

总结答案

随机分配到微流控精子准备的患者与接受标准 IVF-ICSI 精子处理的患者相比，具有相似的卵裂和囊胚期胚胎质量以及临床妊娠率和持续妊娠率。

已知信息

微流控精子制备可以最小化 DNA 碎片化的情况下分离用于临床使用的精子，但对临床结果的影响尚不清楚。

研究设计、大小、持续时间：这是一项前瞻性随机对照试验，纳入了 2017 年 6 月至 2021 年 9 月期间计划进行 IVF 的 386 名患者。

参与者/材料、地点、方法：192 名患者被分配到使用微流控精子分离装置进行 ICSI 的精子处理组，而 194 名患者被分配到学术医疗中心的临床标准密度梯度离心（对照组）。

主要结果和机会的作用

在意向治疗分析中，高质量卵裂期胚胎分数没有差异[对照组为 66.0（25.8）%，微流控精子制备组为 68.0（30.3）%，P=0.541，绝对差异为 2.0，95%CI（-8.5，4.5）]，或高质量囊胚分数[对照组为 37.4（25.4）%，微流控精子制备组为 37.4（26.2）%，P=0.985，绝对差异为 0.6，95%CI（6，5.9）]。两组间的临床妊娠率或持续妊娠率无差异。

局限性、谨慎的原因：研究人群是包容性的，并未试图分离男性因素不育病例或精子 DNA 碎片化升高的患者。