Device Dossier

MediCult Vitrification Cooling - In vitro fertilization culture medium kit

Device Dossier for MediCult Vitrification Cooling - In vitro fertilization culture medium kit (In vitro fertilization culture medium kit, Class III,…

Intended purpose

For vitrification of human oocytes, cleavage stage embryos and blastocysts. This product is for Assisted Reproductive Technology (ART) laboratory procedures. The product should only be used by professionals trained in ART treatment.

Functional description

Consists of two solutions, Equilibration Medium (EM) and Vitrification Medium (VM). Oocytes, cleavage stage embryos or blastocysts are equilibrated in first medium for 5-15 minutes depending on stage of development, then second medium for 1 minute before being vitrified (ultra rapid freezing). Solutions provide physiological salts, amino acids and cryoprotectants to enable oocytes to survive the vitrification process.

TGA Public Summary