Objective: To evaluate the effect of adding follicular-fluid meiosis-activating sterol (FF-MAS) in a novel 0.2%recombinant human albumin-based formulation to cumulus-enclosed oocytes on chromosomal status and development of pre-embryos. Design: Multicenter, prospective, randomized, open (doubleblind for vehicle and FF-MAS groups), four parallel groups, controlled trial. Setting: Four public IVF clinics in Denmark. Patient(s): Two hundred eighteen women undergoing IVF donated 483 oocytes. Intervention(s): 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. Main Outcome Measure(s): 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. Result(s): 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. Conclusion(s): 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.
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