Device Dossier

PVP Clinical Grade - In vitro fertilization culture medium

Device Dossier for PVP Clinical Grade - In vitro fertilization culture medium (In vitro fertilization culture medium, Class III, sponsor Origio). ARTG…

Intended purpose

For slowing down the movement of the spermatozoa for ICSI. This product is for Assisted Reproductive Technology (ART) laboratory procedures. The product should only be used by professionals trained in ART treatment.

Functional description

A viscous solution of polyvinylpyrrolidone that facilitates manipulation and selection of sperm during ICSI. Functions by immobilising spermatozoa without impairing acrosome reaction thereby making them easier to catch with an ICSI pipette whilst providing suitable physical and chemical conditions for the sperm. Prior to use, this medium must be pre-equilibrated in a CO2 incubator at 37 degrees celcius. The product is used according to standard principles within the ART laboratory.

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