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.
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.
Loft
Anne
A
Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Aloft@RH.DK
Bergh
Christina
C
Ziebe
Søren
S
Lundin
Kersti
K
Andersen
Anders Nyboe
AN
Wikland
Matts
M
Kim
Hansoo
H
Arce
Joan Carles
JC
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
D002782:Cholestenes; D000431:Ethanol; C100324:4,4-dimethylcholesta-8,14,24-trienol