Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope.

OBJECTIVE: To determine whether incubation in the integrated EmbryoScope time-lapse monitoring system (TMS) and selection supported by the use of a multivariable morphokinetic model improve reproductive outcomes in comparison with incubation in a standard incubator (SI) embryo culture and selection based exclusively on morphology. DESIGN: Prospective, randomized, double-blinded, controlled study. SETTING: University-affiliated private in vitro fertilization (IVF) clinic. PATIENT(S): Eight hundred forty-three infertile couples undergoing intracytoplasmic sperm injection (ICSI). INTERVENTION(S): No patient intervention; embryos cultured in SI with development evaluated only by morphology (control group) and embryos cultured in TMS with embryo selection was based on a multivariable model (study group). MAIN OUTCOME MEASURE(S): Rates of embryo implantation, pregnancy, ongoing pregnancy (OPR), and early pregnancy loss. RESULT(S): Analyzing per treated cycle, the ongoing pregnancy rate was statistically significantly increased 51.4% (95% CI, 46.7-56.0) for the TMS group compared with 41.7% (95% CI, 36.9-46.5) for the SI group. For pregnancy rate, differences were not statistically significant at 61.6% (95% CI, 56.9-66.0) versus 56.3% (95% CI, 51.4-61.0). The results per transfer were similar: statistically significant differences in ongoing pregnancy rate of 54.5% (95% CI, 49.6-59.2) versus 45.3% (95% CI, 40.3-50.4) and not statistically significant for pregnancy rate at 65.2% (95% CI, 60.6-69.8) versus 61.1% (95% CI, 56.2-66.1). Early pregnancy loss was statistically significantly decreased for the TMS group with 16.6% (95% CI, 12.6-21.4) versus 25.8% (95% CI, 20.6-31.9). The implantation rate was statistically significantly increased at 44.9% (95% CI, 41.4-48.4) versus 37.1% (95% CI, 33.6-40.7). CONCLUSION(S): The strategy of culturing and selecting embryos in the integrated EmbryoScope time-lapse monitoring system improves reproductive outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NCT01549262.

Quality of additional embryos transferred on pregnancy outcomes in IVF: predictions using a mathematical approach.

This study assessed the influence of adding embryos with different embryo quality on pregnancy rate and multiple pregnancy rate (MPR). The study included 1891 IVF transfers performed at two centres with different embryo transfer policies. Pregnancy rate and MPR were analysed following three models and then including embryo quality. A predictive mathematical model and two scatter plots were constructed. The model based on embryo independence was incompatible with the observed data, while both the ground and collaborative models provided excellent fits. The collaborative model, however, predicted multiple pregnancies, especially triplets, more accurately. Transfer of additional embryos, irrespective of embryo quality, always increased pregnancy rate and MPR. When implantation rate was low, there was a marked increase in pregnancy rate but only a relatively small increase in MPR. In contrast, with higher implantation rates, the increase in pregnancy rate was mainly due to the increase in MPR, with the same singleton pregnancy rate. Transfer of additional embryos, irrespective of embryo quality, follows a collaborative pattern and always results in an increase in pregnancy rate and MPR. The scatter plots accurately predicted the influence of the different combinations of number and embryo quality on pregnancy rate and MPR.