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

Abstract

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.

Keywords: Early pregnancy loss; embryo culture; embryo selection; implantation; ongoing pregnancy rate; time-lapse.