Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope
Irene Rubio, Arancha Galán, Zaloa Larreategui, Fernando Ayerdi, Jose Bellver, Javier Herrero, Marcos Meseguer, Irene Rubio, Arancha Galán, Zaloa Larreategui, Fernando Ayerdi, Jose Bellver, Javier Herrero, Marcos Meseguer
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.
Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed