Clinical validation of embryo culture and selection by morphokinetic analysis A randomized controlled trial of the EmbryoScope

Capsule:
An alternative strategy for embryo selection based on a multivariable morphokinetic model combined with continuous incubation in an integrated timelapse monitoring system improves the clinical results.

Authors:
Irene Rubio, Ph.D., Arancha Galan, Ph.D., Zaloa Larreategui, Ph.D., Jose Bellver, M.D., Fernando Ayerdi, Ph.D., Javier Herrero, Ph.D., Marcos Meseguer, Ph.D.

Volume 102, Issue 5, Pages 1287-1294

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) setting.

Patient(s):
843 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.

Translate »