与标准手工胚胎学相比，延时成像封闭胚胎培养系统（EmbryoScope™）在预后良好和预后不良患者中的不同有效性：一项前瞻性随机试验研究。
Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study.
作者信息
Wu Yan-Guang, Lazzaroni-Tealdi Emanuela, Wang Qi, Zhang Lin, Barad David H, Kushnir Vitaly A, Darmon Sarah K, Albertini David F, Gleicher Norbert
机构信息
The Center for Human Reproduction, 21 East 69th Street, New York, NY, 10021, USA.
The Foundation for Reproductive Medicine, New York, NY, 10021, USA.
出版信息
Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.
BACKGROUND
Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated. We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology. We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology. We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo.
RESULTS
Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time (P < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P = 0.005 and P = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation.
CONCLUSIONS
Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled utilization of these instruments further expands.
TRIAL REGISTRATION
NCT02246309 Registered September 18, 2014.
背景
以前，许多体外受精（IVF）中心的人工胚胎学操作正迅速被带有延时成像功能的封闭式胚胎培养系统所取代。然而，此前从未有人研究过此类系统在不同IVF患者群体中与人工胚胎学操作的表现是否相当。因此，我们前瞻性地比较了采用延时摄影的封闭式系统培养（EmbryoScope™）与标准胚胎学操作后的胚胎质量。我们在IVF中进行了一项分为两部分的前瞻性随机研究（临床试验编号：NCT92256309）。A部分纳入了31例预后不良的不孕患者，将其前瞻性随机分为EmbryoScope™组和标准胚胎学操作组。B部分涉及17个供卵 - 受者周期的胚胎，产生了大量的卵子/胚胎，从而能够前瞻性地将胚胎分配至EmbryoScope™组和标准胚胎学操作组。然后，我们比较了受精后第3天的妊娠率、胚胎质量以及每个处理胚胎所花费的胚胎学家时间。
结果
A部分显示，在预后不良的患者中，EmbryoScope™组和标准胚胎学操作组在第3天的胚胎评分、着床率和临床妊娠率方面没有差异。然而，EmbryoScope™使胚胎学工作人员的时间增加了一倍多（P < 0.0001）。在B部分中，在EmbryoScope™中培养的胚胎在第3天的质量明显较差（根据胚胎参数，P值在0.005至0.01之间）。当标准培养皿在标准培养中显示出无结果差异时，对EmbryoScope™（EmbryoSlide™）的锥形培养皿可能是原因的怀疑被推翻。
结论
尽管由于患者数量较少，本研究结果具有初步性，但该研究引发了人们对将带有延时成像功能的封闭式培养系统在大多未加控制的情况下引入常规临床胚胎学的担忧。在这些仪器不受控制的使用进一步扩大之前，似乎迫切需要在明确界定的患者群体中进行设计合理、样本量充足的前瞻性随机研究。
试验注册
NCT02246309，于2014年9月18日注册。
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