SpermFreezeTM / SpermFreezeTM SSP

Intended use

SpermFreezeTM and SpermFreezeTM SSP are media for cryopreservation of human sperm for further use in Assisted Reproductive Technologies.

SpermFreezeTM SSP is a more concentrated cryopreservation medium which allows a higher volume of sperm to be cryopreserved:
SpermFreezeTM requires 0.7-1ml medium for 1ml sperm
SpermFreezeTM SSP requires 1ml medium for 3ml sperm

SpermFreezeTM and SpermFreezeTM SSP are ready-to-use.

Composition

SpermFreezeTM and SpermFreezeTM SSP are HEPES-buffered media which also contains physiologic salts, glycine, glucose, lactate, and the cryoprotectants glycerol (15% and 27% for SpermFreezeTM and SpermFreezeTM SSP respectively), sucrose and human serum albumin (4.0g/l, medicinal substance derived from human blood plasma) to protect the sperm from damage during the freezing procedure.

Further information on the composition of the media can be found in the material safety data sheet.

Regulatory

  • Europe: CE-marked (MDR, Notified Body number 2797)
  • USA: US FDA Cleared
  • Canada: Health Canada License (only SpermFreezeTM)
  • Brazil: Registered
  • Other regions: Information available upon request

Product order codes

SPF05 : 25 x 5ml – SpermFreezeTM
SPF : 5 x 20ml – SpermFreezeTM

SSP001 : 5 x 1ml – SpermFreezeTM SSP

pH 7.20-7.90 (7.20-7.60 at product release)
Sterility test by the current Ph. Eur. 2.6.1./ USP <71> No growth
Endotoxin < 0.25 EU/ml
Human sperm survival assay (% motility compared with control after 4 hours exposure to test medium) ≥ 80%
Concentration human serum albumin 3.2-4.8 g/l
Shelf life 18 months from date of production

Cryopreservation

SpermFreezeTM and SpermFreezeTM SSP are cryopreservation media for human spermatozoa

SpermFreeze
Instructions For Use
Summary of safety and clinical performance
Material Safety Data Sheet – SpermFreezeTM
Material Safety Data Sheet – SpermFreezeTM SSP