title: 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.
  
  
  METHODS
  Prospective, randomized, double-blinded, controlled study.
  
  
  METHODS
  University-affiliated private in vitro fertilization (IVF) clinic.
  
  
  METHODS
  Eight hundred forty-three infertile couples undergoing intracytoplasmic sperm injection (ICSI).
  
  
  METHODS
  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).
  
  
  METHODS
  Rates of embryo implantation, pregnancy, ongoing pregnancy (OPR), and early pregnancy loss.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  The strategy of culturing and selecting embryos in the integrated EmbryoScope time-lapse monitoring system improves reproductive outcomes.
  
  
  BACKGROUND
  NCT01549262.
authors.affiliation: Instituto Universitario IVI Valencia, University of Valencia, Valencia, Spain.
authors.forename: Irene
authors.initials: I
authors.lastname: Rubio
authors.affiliation: Instituto Universitario IVI Valencia, University of Valencia, Valencia, Spain.
authors.forename: Arancha
authors.initials: A
authors.lastname: Galán
authors.affiliation: IVI Bilbao, Bilbao, Spain.
authors.forename: Zaloa
authors.initials: Z
authors.lastname: Larreategui
authors.affiliation: IVI Bilbao, Bilbao, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Ayerdi
authors.affiliation: Instituto Universitario IVI Valencia, University of Valencia, Valencia, Spain.
authors.forename: Jose
authors.initials: J
authors.lastname: Bellver
authors.affiliation: Instituto Universitario IVI Valencia, University of Valencia, Valencia, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Herrero
authors.affiliation: Instituto Universitario IVI Valencia, University of Valencia, Valencia, Spain. Electronic address: marcos.meseguer@ivi.es.
authors.forename: Marcos
authors.initials: M
authors.lastname: Meseguer
mesh_terms: D000293:Adolescent; D000328:Adult; D046149:Embryo Culture Techniques / Q000295:instrumentation*; D004624:Embryo Transfer / Q000295:instrumentation*; D004622:Embryo, Mammalian / Q000166:cytology*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D020669:Fetoscopes; D006801:Humans; D007185:Incubators; D007247:Infertility, Female / Q000473:pathology / Q000628:therapy*; D018715:Microscopy, Video / Q000295:instrumentation / Q000379:methods; D011247:Pregnancy; D011256:Pregnancy Outcome; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D059008:Time-Lapse Imaging / Q000295:instrumentation* / Q000379:methods; D055815:Young Adult
keywords: Early pregnancy loss; embryo culture; embryo selection; implantation; ongoing pregnancy rate; time-lapse