title: A randomized, double-blind, controlled trial of the effect of adding follicular fluid meiosis activating sterol in an ethanol formulation to donated human cumulus-enclosed oocytes before fertilization.
abstract: OBJECTIVE
  To evaluate the effect of follicular fluid meiosis activating sterol (FF-MAS) in a 0.2% ethanol formulation on chromosomal status and development of preembryos.
  
  
  METHODS
  Multicenter, prospective, randomized, double-blind, five parallel group, controlled trial.
  
  
  METHODS
  Public and private IVF-clinics in Denmark and Sweden.
  
  
  METHODS
  Two hundred ten women undergoing IVF treatment donated 310 oocytes.
  
  
  METHODS
  FSH/hCG primed cumulus-enclosed oocytes randomized to 4 hours exposure of medium with 0.1, 1, or 10 microM FF-MAS dissolved in 0.2% ethanol, medium with ethanol 0.2%, or medium with water for injection (control) before insemination.
  
  
  METHODS
  Primary: incidence of human preembryos with chromosomal abnormalities. Secondary: fertilization rate, cleavage rate, and preembryo quality after 68 hours of culture.
  
  
  RESULTS
  At the preembryo level, no significant differences in chromosomal abnormality rate were found among any of the groups. At the blastomere level, a significant increased abnormality rate was observed in the ethanol group and the combined FF-MAS groups compared with the control group. No significant differences in fertilization rate, cleavage rate, or preembryo quality were observed among any of the groups and the control group except for a significant reduction in the number of embryos with >or=2 cells at 26 hours in the ethanol group.
  
  
  CONCLUSIONS
  No negative effect of FF-MAS was observed. However, addition of ethanol 0.2% to standard IVF-medium with or without FF-MAS for culturing cumulus-enclosed oocytes for 4 hours before insemination increased the chromosomal abnormality rate at the blastomere level. Further studies of FF-MAS in a nonethanol formulation are under way.
authors.affiliation: Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Aloft@RH.DK
authors.forename: Anne
authors.initials: A
authors.lastname: Loft
authors.forename: Christina
authors.initials: C
authors.lastname: Bergh
authors.forename: Søren
authors.initials: S
authors.lastname: Ziebe
authors.forename: Kersti
authors.initials: K
authors.lastname: Lundin
authors.forename: Anders Nyboe
authors.initials: AN
authors.lastname: Andersen
authors.forename: Matts
authors.initials: M
authors.lastname: Wikland
authors.forename: Hansoo
authors.initials: H
authors.lastname: Kim
authors.forename: Joan Carles
authors.initials: JC
authors.lastname: Arce
mesh_terms: D000328:Adult; D001757:Blastomeres / Q000502:physiology; D002478:Cells, Cultured; D002782:Cholestenes / Q000494:pharmacology*; D002869:Chromosome Aberrations; D020732:Cytogenetic Analysis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004339:Drug Compounding / Q000379:methods; D004622:Embryo, Mammalian / Q000502:physiology*; D000431:Ethanol; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D015571:Follicular Fluid / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008540:Meiosis; D018587:Oocyte Donation; D009865:Oocytes / Q000187:drug effects / Q000502:physiology*; D006080:Ovarian Follicle / Q000166:cytology / Q000187:drug effects / Q000502:physiology
chemical_list: D002782:Cholestenes; D000431:Ethanol; C100324:4,4-dimethylcholesta-8,14,24-trienol