Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScopeTM) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study

Abstract

BackgroundPreviously 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.ResultsPart 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.ConclusionsThough 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 registrationNCT02246309 Registered September 18, 2014.

Embryo Morphokinetics Based on Time-Lapse Observation

“…These results are in line with other studies, which showed similar results in good quality embryos, embryo development, blastocyst rate, implantation, and ongoing pregnancy rates between customary culture and TLS [14][15][16]. In the same way, in a two-part study, poor-prognosis patients have shown no diferences in Day-3 embryo quality, implantation, and clinical pregnancy rates between embryos cultured in EmbryoScope™ and conventional culture, whereas in the second portion, embryos developed in the EmbryoScope™ revealed signiicantly poorer quality on Day 3 compared to standard-cultured embryos [17]. Likewise, in a recent study, a total of 2092 embryos undergoing IVF cycles were evaluated by conventional morphology assessment or TLS.…”

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials

“…Three studies investigated the outcome of good quality embryo on Day 2/3[24, 26, 28], and no significant effect on this outcome was observed between TLI group and control group (RR 0.89, 95% CI 0.72–1.11, I2 = 42%, three studies, including 720 embryos). Results of pooled analysis of the oocyte-based review were showed in Fig 2.…”

Embryo wastage rates remain high in assisted reproductive technology (ART): a look at the trends from 2004–2013 in the USA

“…However, prospective studies are still needed to clarify algorithms for analyzing this data and proving, unequivocally, a significant benefit to patients [9]. Very recent randomized controlled trials have failed to show any benefit by adopting time lapse technology over morphology in improving pregnancy and delivery rates [13,14]. Fourth, we can consider modifying our protocols of ovarian stimulation to avoid the production of too many oocytes, which, as demonstrated here and in previous studies, may not lead to more live births, but to increased BEmbryo Wastages.M inimal stimulation or natural IVF cycles have been associated with improved egg quality and reduced aneuploidy rates [37][38][39].…”

“…Morphologic criteria to grade embryos correlate poorly with pregnancy and live birth rates and fail to identify chromosomally normal embryos [5][6][7]. The utilization of time-lapse embryo growth monitoring systems has also gained popularity, but data convincingly demonstrating improved outcomes as a result of this technology is still lacking [8][9][10][11][12][13][14].…”