Device Dossier
SAGE 1-Step - In vitro fertilization culture medium
Device Dossier for SAGE 1-Step - In vitro fertilization culture medium (In vitro fertilization culture medium, Class III, sponsor Origio). ARTG record,…
- GMDN category: In vitro fertilization culture medium
Intended purpose
This product is intended for the in vitro fertilisation and culture of human gametes and embryos from fertilisation until Day 5/6 of development. The medium can also be used for embryo transfer. This product is for ART treatment, whether the cause of infertility is male or female. The product should only be used by professionals trained in ART treatment.
Functional description
SAGE 1-Step is a sterile, non-viscous solution, in PETG bottles with HDPE cap. The medium is equilibrated at 37°C and 5-6% CO for a minimum of 2 hours. Oocytes can be fertilized in SAGE 1-Step. Embryos are cultured in SAGE 1-Step at 37°C, 5-6% C02 and 5 or 21% 02 for up to 6 days. If the SAGE 1-Step is used for transfer, catheters are flushed with SAGE 1-Step prior to the procedure. Embryos are afterwards transferred back to the uterus in pre-equilibrated fresh SAGE 1-Step.