Impact of follicular-fluid meiosis-activating sterol in an albumin-based formulation on the incidence of human pre-embryos with chromosome abnormalities
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文摘

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 (double-blind 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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