10% PVP in FertiCultTM Flushing medium

Intended use

10% PVP in FertiCultTM Flushing medium is a viscous medium containing polyvinylpyrrolidone (PVP) used for sperm preparation for Intracytoplasmic Sperm Injection (ICSI). These procedures require the capture of individual sperm cells in a glass pipette for injection into the oocyte and this is facilitated by first immobilizing the sperm by placing them in a viscous medium like 10% PVP in FertiCultTM Flushing medium prior to nicking the tail to immobilize sperm completely.

10% PVP in FertiCultTM Flushing medium is ready-to-use.

Composition

10% (w/v) dialysed Ph. Eur. grade polyvinylpyrrolidone (PVP) in FertiCultTM Flushing medium. FertiCultTM Flushing medium is an aqueous solution containing HEPES, bicarbonate, physiologic salts, glucose, lactate, pyruvate and human serum albumin (4.0g/l, medicinal substance derived from human blood plasma).

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

Regulatory

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

Product order codes

PVP0.2S : 5 x 0.2ml 10% PVP in FertiCultTM Flushing medium
PVP1 : 1 x 1ml 10% PVP in FertiCultTM Flushing medium

pH 7.20-7.90 (7.20-7.60 at product release)
Osmolality 280-340 mOsm/kg (280-320mOsm/kg at product release)
Sterility test by the current Ph. Eur. 2.6.1./ USP <71> No growth
Viscosity >170cP at 25°C
Endotoxin <0.5 EU/ml
Human sperm survival assay (% motility compared with control after 60 minutes exposure to test medium) ≥ 80%
Concentration human serum albumin 3.2-4.8 g/l
Mouse embryo assay (% blastocysts at 96 hours, after 10 minutes exposure to test medium) ≥80%
Shelf life 9 months from date of production

Sperm Processing

Viscous medium for easy sperm capture in ICSI procedures

10%_PVP
Instructions For Use
Summary of safety and clinical performance
Material Safety Data Sheet