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.
Highlights
Manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging
Part A: time-lapse imaging (TLI) system vs. standard embryo culture system system in infertile women Patient comparisons Randomization of 31 infertile patients resulted in 16 patients going through TLI and 15 through standard embryology (Fig. 1a)
Patient and IVF cycle characteristics involved in this study are summarized in Tables 1 and 2: Mean age in the EmbryoScopeTM group (38.8 ± 1.0 years) was nonsignificantly lower than in the standard embryology group (40.4 ± 1.8 years)
Summary
Manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Improvements in the embryology laboratory have been a consisten goal of in vitro fertilization (IVF) Over the years this has led to significant changes in how human embryos are processed: New culture media have been introduced [1, 2]; length of embryo culture has in many IVF centers changed from 2–3 days to 5–6 days) [3, 4]; and culture at reduced oxygen tension has been reported to improve embryo development and clinical pregnancy rates [5, 6]. By minimizing environmental fluctuations in temperature, pH and humidity, supporters of such closed incubation systems have argued that embryo quality would be improved and, clinical outcomes They suggested that continuous time-lapse documentation of embryo development would improve embryo selection and, thereby, further improve pregnancy chances [12,13,14,15,16]. Till today it is unknown whether embryos from different patient populations (ie, good vs. poor prognosis or younger vs, older patients) are affected differently by such culture systems
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