Multicenter, prospective, randomized, open (double-blind for vehicle and FF-MAS groups), four parallel groups, controlled trial.
Four public IVF clinics in Denmark.
Two hundred eighteen women undergoing IVF donated 483 oocytes.
Follicle-stimulating hormone/hCG-primed cumulus-enclosed oocytes randomized to 4 hours of exposure to medium with 1 or 10 μmol/L of FF-MAS dissolved in 0.2 % recombinant human albumin, medium with 0.2 % recombinant human albumin (vehicle control), or medium alone (control) before insemination.
Primary endpoint: incidence of human pre-embryos with chromosomal abnormalities. Secondary endpoint: fertilization rate, cleavage rate, and pre-embryo quality assessed after 68 hours of culture.
At pre-embryo level, the overall abnormality rates in the control, vehicle control, and 1- and 10-μmol/L FF-MAS groups were 53 % , 39 % , 42 % , 53 % , respectively, and at blastomere level 49 % , 44 % , 44 % , and 48 % , respectively. After 20 and 26 hours, the fertilization rates were between 67 % and 71 % in all groups. No differences in the cleavage rates were observed.
The concentrations of FF-MAS in a novel 0.2 % recombinant human albumin–based formulation of FF-MAS did not increase the risk of chromosomal abnormalities in pre-embryos or blastomeres. No statistically significant differences in fertilization rate, cleavage rate, or number of good quality pre-embryos were found among the four groups.