IVI Valencia, Valencia, Spain.
IVI Bilbao, Bilbao, Spain.
Fertil Steril. 2017 Sep;108(3):498-504. doi: 10.1016/j.fertnstert.2017.06.031.
To compare obstetric and perinatal outcomes of singleton pregnancies resulting from embryos incubated in a time-lapse system (TLS) with those of embryos grown in standard IVF incubators (SI).
Retrospective description of a cohort of patients who conceived during a randomized, controlled trial.
Private university-affiliated IVF center.
PATIENT(S): Of 856 randomized patients, 378 gave birth to a live-born infant: 216 of the deliveries originated from embryos incubated in TLS, and 162 deliveries were from embryos cultured in SI.
INTERVENTION(S): Embryo incubation and selection in TLS.
MAIN OUTCOME MEASURE(S): Delivery and neonatal outcomes.
RESULT(S): No significant differences were observed in the baseline characteristics of the study population. The delivery rate was 49.3% (TLS) vs. 40.0% (SI), and multiple deliveries were higher in the TLS group: 31.0% (67 of 216) vs. 24.7% (40 of 162) in the SI group. When singleton pregnancies were analyzed no differences were found between the two groups in the rate of obstetric problems with respect to weeks at delivery: 38.8 (95% confidence interval [CI] 38.4-39.1) (TLS) vs. 39.5 (95% CI 38.0-39.9) (SI); preterm births (<37 weeks): 10.7% (TLS) vs. 12.3% (SI); and very preterm births (<34 weeks): 2.9% (TLS) vs. 3.3% (SI). No statistical differences were found in neonatal outcomes such as birth weight: 3,163 g (95% CI 3,035-3,292 g) (TLS) vs. 3,074 (95% CI 2,913-3,236) (SI); low birth weight (<2,500 g): 12.8% (TLS) vs. 12.3% (SI); very low birth weight (<1,500 g): 2.0% (TLS) vs. 2.4% (SI); or height: 50.3 cm (95% CI 49.6-50.9 cm) (TLS) vs. 49.7 (95% CI 48.9-50.4 cm) (SI). No major malformations or perinatal mortality were found in either of the two groups.
CONCLUSION(S): No detrimental effects were observed in obstetric and perinatal outcomes when a time-lapse incubator was used rather than a more widely used conventional incubator. As far as we know this is the first report from a randomized study of the neonatal outcomes of time-lapse monitoring. Our results suggest that this technology is an effective and safe alternative for embryo incubation, though trials of larger numbers of patients are required to further confirm our conclusions.
NCT01549262.
比较使用时间延迟系统（TLS）孵育的胚胎与使用标准 IVF 孵育器（SI）孵育的胚胎的单胎妊娠的产科和围产儿结局。
对随机对照试验中受孕的患者进行回顾性描述。
私立大学附属 IVF 中心。
在 856 名随机患者中，有 378 名分娩出活产婴儿：216 名婴儿来自于 TLS 孵育的胚胎，162 名婴儿来自于 SI 孵育的胚胎。
TLS 中的胚胎孵育和选择。
分娩和新生儿结局。
研究人群的基线特征无显著差异。分娩率分别为 49.3%（TLS）和 40.0%（SI），TLS 组的多胎分娩率更高：31.0%（67/216）和 24.7%（40/162）在 SI 组中。当分析单胎妊娠时，两组在分娩时的产科问题发生率方面没有差异：38.8（95%置信区间[CI]38.4-39.1）（TLS）和 39.5（95%CI38.0-39.9）（SI）；早产（<37 周）：10.7%（TLS）和 12.3%（SI）；极早产（<34 周）：2.9%（TLS）和 3.3%（SI）。新生儿结局如出生体重无统计学差异：3163g（95%CI3035-3292g）（TLS）和 3074g（95%CI2913-3236）（SI）；低出生体重（<2500g）：12.8%（TLS）和 12.3%（SI）；极低出生体重（<1500g）：2.0%（TLS）和 2.4%（SI）；或身高：50.3cm（95%CI49.6-50.9cm）（TLS）和 49.7cm（95%CI48.9-50.4cm）（SI）。两组均未发现重大畸形或围产儿死亡。
当使用时间延迟孵育器而不是更广泛使用的传统孵育器时，产科和围产儿结局未观察到有害影响。据我们所知，这是第一项关于时间延迟监测新生儿结局的随机研究报告。我们的结果表明，这项技术是一种有效的和安全的胚胎孵育替代方法，尽管需要更大数量的患者进行试验以进一步证实我们的结论。
NCT01549262。
