Device Dossier

MediCult IVM System - In vitro fertilization culture medium kit

Device Dossier for MediCult IVM System - In vitro fertilization culture medium kit (In vitro fertilization culture medium kit, Class III, sponsor…

Intended purpose

For pre-incubation and in vitro maturation of immature oocytes. This product is for Assisted Reproductive Technology (ART) laboratory procedures. The product should only be used by professionals trained in ART treatment.

Functional description

Immature oocytes are stored in LAG Medium in a CO2 incubator for 2-3 hours, then transferred to 3mL LAG Medium with 10mL IVM Medium that has been pre-equilibrated for a minimum of 12 hours and supplemented with 10% patient's own serum, 100 mIU/mL hCG & 75 mIU/mL FSH. The oocytes are then incubated in the supplemented IVM Medium in a CO2 environment at 37 degrees C for 28-32 hours.

TGA Public Summary