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胚胎自然运动(enMotion):一项评估动态胚胎培养系统的配对随机对照试验。

Embryo's Natural Motion (enMotion): a paired randomized controlled trial evaluating a dynamic embryo culture system.

机构信息

Audubon Fertility, New Orleans, Louisiana.

Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey.

出版信息

Fertil Steril. 2020 Mar;113(3):578-586.e1. doi: 10.1016/j.fertnstert.2019.09.043. Epub 2020 Feb 7.

Abstract

OBJECTIVE

To determine if a dynamic embryo culture system affects the reproductive potential of human embryos resulting from in vitro fertilization (IVF).

DESIGN

Paired randomized controlled trial (RCT).

SETTING

IVF center.

PATIENT(S): IVF patients with normal ovarian reserve eligible for two-embryo transfer.

INTERVENTION

IVF care was routine until fertilization was confirmed. Two-pronuclear embryos (2PNs) were then randomized: One-half of each patient's 2PNs were cultured in dynamic culture and one-half in static culture. Preimplantation genetic testing for embryonic aneuploidy was used to control for aneuploidy and allow for DNA fingerprinting. The best euploid blastocyst from each culture system was selected and patients underwent a frozen two-embryo transfer. If a singleton gestation resulted, DNA-fingerprinting was used to determine which of the two blastocysts implanted. The dynamic platform used was the NSSB-300 (Nepagene).

MAIN OUTCOME MEASURE(S): The primary outcome was the proportion of usable blastocysts obtained. The secondary outcome was sustained implantation rate (SIR).

RESULT(S): One hundred participants completed oocyte retrieval and blastocyst vitrification for frozen-thawed embryo transfer; 609 dynamic 2PNs and 615 static 2PNs were followed; and 304 blastocysts developed in dynamic culture and 333 blastocysts developed in static culture. In the paired analysis, the rate of usable blastulation was similar between dynamic and static culture (58.3% vs. 57.1%). In addition, there was no difference in the rate of aneuploidy (20.0% vs. 33.3%) or SIR (67.1% vs. 63.1%) between groups.

CONCLUSION(S): In this paired RCT, dynamic culture did not improve usable blastulation rate or SIR.

CLINICAL TRIAL REGISTRATION NUMBER

NCT02467725.

摘要

目的

确定胚胎动态培养系统是否会影响体外受精(IVF)产生的人类胚胎的生殖潜能。

设计

配对随机对照试验(RCT)。

地点

IVF 中心。

患者

有资格进行双胚胎移植的卵巢储备正常的 IVF 患者。

干预措施

在受精确认之前,IVF 护理是常规的。然后将二核胚胎(2PN)随机分组:每位患者的一半 2PN 在动态培养中,另一半在静态培养中。胚胎非整倍体的胚胎植入前遗传学检测用于控制非整倍体并允许 DNA 指纹识别。从每个培养系统中选择最好的整倍体囊胚,并进行冷冻的双胚胎移植。如果单胎妊娠,则使用 DNA 指纹识别来确定植入的两个囊胚中的哪一个。使用的动态平台是 NSSB-300(Nepagene)。

主要观察指标

主要结局是获得的可使用囊胚的比例。次要结局是持续着床率(SIR)。

结果

100 名参与者完成了卵母细胞采集和冷冻解冻胚胎移植的囊胚玻璃化;609 个动态 2PN 和 615 个静态 2PN 进行了随访;在动态培养中发育了 304 个囊胚,在静态培养中发育了 333 个囊胚。在配对分析中,动态培养和静态培养的可使用囊胚形成率相似(58.3%对 57.1%)。此外,两组之间的非整倍体率(20.0%对 33.3%)或 SIR(67.1%对 63.1%)无差异。

结论

在这项配对 RCT 中,动态培养并未提高可使用囊胚形成率或 SIR。

临床试验注册号

NCT02467725。

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