title: Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup.
abstract: OBJECTIVE
  To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media.
  
  
  METHODS
  Randomized, double-blinded sibling trial.
  
  
  METHODS
  Independent in vitro fertilization (IVF) clinics.
  
  
  METHODS
  One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms.
  
  
  METHODS
  Embryos randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media.
  
  
  METHODS
  Percentage of good-quality blastocysts on day 5.
  
  
  RESULTS
  Percentage of day 5 good-quality blastocysts was 21.1% (standard deviation [SD] ± 21.6%) and 22.2% (SD ± 22.1%) in the single-step time-lapse medium (G-TL) and the sequential media (G-1/G-2) groups, respectively. The mean difference (-1.2; 95% CI, -6.0; 3.6) between the two media systems for the primary end point was less than the noninferiority margin of -8%. There was a statistically significantly lower number of good-quality embryos on day 3 in the G-TL group [50.7% (SD ± 30.6%) vs. 60.8% (SD ± 30.7%)]. Four out of the 11 measured morphokinetic parameters were statistically significantly different for the two media used. The mean levels of ammonium concentration in the media at the end of the culture period was statistically significantly lower in the G-TL group as compared with the G-2 group.
  
  
  CONCLUSIONS
  We have shown that a single-step culture medium supports blastocyst development equivalently to established sequential media. The ammonium concentrations were lower in the single-step media, and the measured morphokinetic parameters were modified somewhat.
  
  
  BACKGROUND
  NCT01939626.
authors.affiliation: Fertilitetscentrum, Carlanderska Hospital, Gothenburg, Sweden. Electronic address: thorir.hardarson@fertilitetscentrum.se.
authors.forename: Thorir
authors.initials: T
authors.lastname: Hardarson
authors.affiliation: Reproductive Medicine Centre, Skåne University Hospital, Malmö, Sweden.
authors.forename: Mona
authors.initials: M
authors.lastname: Bungum
authors.affiliation: Pacific Fertility Center, San Francisco, California.
authors.forename: Joe
authors.initials: J
authors.lastname: Conaghan
authors.affiliation: Frisco Institute for Reproductive Medicine, Dallas/Austin, Texas.
authors.forename: Marius
authors.initials: M
authors.lastname: Meintjes
authors.affiliation: Frisco Institute for Reproductive Medicine, Dallas/Austin, Texas.
authors.forename: Samuel J
authors.initials: SJ
authors.lastname: Chantilis
authors.affiliation: MediBit Foundation, Budapest, Hungary.
authors.forename: Laszlo
authors.initials: L
authors.lastname: Molnar
authors.affiliation: Fertilitetscentrum, Carlanderska Hospital, Gothenburg, Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Gunnarsson
authors.affiliation: Fertilitetscentrum, Carlanderska Hospital, Gothenburg, Sweden.
authors.forename: Matts
authors.initials: M
authors.lastname: Wikland
mesh_terms: D064751:Ammonium Compounds / Q000378:metabolism; D001755:Blastocyst / Q000378:metabolism / Q000502:physiology*; D003470:Culture Media / Q000737:chemistry* / Q000378:metabolism; D004311:Double-Blind Method; D046149:Embryo Culture Techniques; D010064:Embryo Implantation; D004624:Embryo Transfer; D047108:Embryonic Development; D005260:Female; D005298:Fertility; D005307:Fertilization in Vitro; D006801:Humans; D007246:Infertility / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D050498:Live Birth; D008297:Male; D009024:Morphogenesis; D011247:Pregnancy; D018873:Pregnancy Rate; D011446:Prospective Studies; D013548:Sweden; D013997:Time Factors; D059008:Time-Lapse Imaging; D014481:United States
chemical_list: D064751:Ammonium Compounds; D003470:Culture Media
keywords: Blastocyst; sequential media; single-step medium; time-lapse; undisturbed culture