使用同胞卵母细胞的多年结果证明了一种简化培养系统在低成本体外受精环境中使用的安全性和有效性。

Multiyear outcomes using sibling oocytes demonstrates safety and efficacy of a simplified culture system consistent with use in a low-cost IVF setting.

作者信息

Ombelet Willem, Van Blerkom Jonathan, Nargund Geeta, Van der Auwera Ingrid, Janssen Mia, Dhont Nathalie, Bosmans Eugene, Boshoff Gerhard, Vertessen Viktor-Jan, Campo Rudi

机构信息

Genk Institute for Fertility Technology, Department of Obstetrics and Gynaecology, ZOL, Campus St Jan, Genk, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Agoralaan, Diepenbeek 3590, Belgium.

Department of Molecular, Cellular and Developmental Biology, University of Colorado, BoulderColorado, USA.

出版信息

Reprod Biomed Online. 2022 Sep;45(3):481-490. doi: 10.1016/j.rbmo.2022.04.008. Epub 2022 Jun 16.

DOI:10.1016/j.rbmo.2022.04.008

PMID:36064261

Abstract

RESEARCH QUESTION

Can a novel closed simplified IVF culture system be used to achieve outcomes comparable to those obtained with intracytoplasmic sperm injection (ICSI) followed by conventional culturing?

DESIGN

This analysis is part of a non-inferiority prospective study comparing ICSI and a simplified culture system (SCS) for gamete fertilization in a selected group of patients. According to protocol, sibling oocytes in intact cumulus-oocyte complexes were randomly distributed between ICSI and conventional insemination in the SCS. For women, selection criteria included being under 43 years of age and at least six eggs at retrieval. An inseminating motile sperm count ≥1 million was required. The primary outcome measure was ongoing pregnancy rate (>12 weeks) per cycle; secondary outcome measures included fertilization rate, miscarriage rate and implantation rate (ongoing pregnancy rate per embryo).

RESULTS

From January 2016 until December 2019, 653 SCS/ICSI cycles were performed yielding a total of 7915 oocytes. The fertilization rate was 61.1% and 50.4% for SCS and ICSI (P < 0.0001), respectively. The ongoing pregnancy rate was 32.0% for SCS and 36.7% for ICSI (P = 0.27). Implantation rate was 30.6% for SCS and 34.4% for ICSI (P = 0.35). The miscarriage rate was 7.5% and 6.5% for SCS and ICSI, respectively (P = 0.75).

CONCLUSION

No difference was found in ongoing pregnancy rate, implantation rate and the miscarriage rate between SCS and ICSI in this selected patient cohort.

摘要

研究问题

一种新型的封闭式简化体外受精培养系统能否用于获得与卵胞浆内单精子注射（ICSI）后传统培养所获得的结果相当的结果？

设计

本分析是一项非劣效性前瞻性研究的一部分，该研究比较了ICSI和一种简化培养系统（SCS）对一组选定患者的配子受精情况。根据方案，完整卵丘-卵母细胞复合体中的同胞卵母细胞被随机分配到ICSI组和SCS组进行常规授精。对于女性，选择标准包括年龄在43岁以下且取卵时至少有6个卵子。要求授精时活动精子计数≥100万。主要结局指标是每个周期的持续妊娠率（>12周）；次要结局指标包括受精率、流产率和着床率（每个胚胎的持续妊娠率）。

结果

2016年1月至2019年12月，共进行了653个SCS/ICSI周期，共获得7915个卵母细胞。SCS组和ICSI组的受精率分别为61.1%和50.4%（P<0.0001）。SCS组的持续妊娠率为32.0%，ICSI组为36.7%（P=0.27）。SCS组的着床率为30.6%，ICSI组为34.4%（P=0.35）。SCS组和ICSI组的流产率分别为7.5%和6.5%（P=0.75）。