FAQ1: Do I need to add egg-yolk to SpermFreeze^TM (SSP) before use?
No, SpermFreeze^TM (SSP) is ready-to-use and does not require any additives.

FAQ2: Does SpermFreeze^TM (SSP) contain antibiotics?
No, SpermFreeze^TM (SSP) does not contain any antibiotics.

FAQ3: Can I use SpermFreeze^TM (SSP) for TESE?
With the CE-marking according to the Regulation (EU) 2017/745, this was omitted from the intended use due to an insufficient amount of clinical data to support this. The past years, efforts were made to collect additional clinical data, making it possible to extend the intended use again. Therefore SpermFreeze^TM can again be used for the cryopreservation of sperm from testicular biopsies (TESE).

In this regard, in order to keep our technical file updated, if you are able to share clinical data on the cryopreservation of sperm from TESE, please contact ra@fertipro.com.

FAQ4: How long can I keep sperm in a frozen state?
Our data support a lifetime of at least 10 years. 20 sperm donations from different donors were frozen with FertiPro Sperm Freezing media between 2005-2009. Samples were thawed after two weeks cryopreservation and after 11-15 years. Progressive sperm motility was compared before and after freezing. An acceptable yield was found after 11-15 years, but progressive sperm motility decreased ±14% (on average) compared to samples thawed after two weeks.

FAQ5: We have noted that after thawing the tails of the spermatozoa are curled. Is this normal?
No this is not normal. Curling of the tail occurs because of osmotic shock when SpermFreeze^TM (SSP) is added to the semen sample. To avoid this, add SpermFreeze^TM (SSP) slowly and dropwise, while swirling the container that holds the semen sample. This way the spermatozoa have ample time to adjust to the new osmotic equilibrium.

FAQ6: What survival rates should we expect after freezing/ thawing ?
The number of sperm cells surviving a freezing procedure can vary significantly between samples and between patients/ donors. In general, a reduction in sperm motility of 50-60% after cryopreservation with SpermFreeze^TM (SSP) is considered as acceptable.

FAQ7: How long can I use SpermFreeze^TM (SSP) after opening the bottle?
We have performed in-use testing on SpermFreeze^TM (SSP) which supports the use of the media up to 7 days, taking into consideration that the bottle was opened under sterile conditions and the product was stored at 2-8°C after opening. In addition and as indicated in the IFU it is advised to:

• Keep the product in its original container until the day of use and
• Depending on the number of procedures that will be performed on one day, remove the required volume of medium under aseptic conditions in an appropriate sterile recipient. This is in order to avoid multiple opening/ warming cycles of the medium. Discard excess (unused) media.

FAQ8: Can SpermFreeze^TM (SSP) also be used with cryotubes instead of straws?
Yes, the same protocol as mentioned in the instructions for use of SpermFreeze^TM (SSP) can be applied.

FAQ9: Why place an air bubble at the end of the straw?
An air bubble is placed at the end of the straw in order to prevent rupture of the seal when the SpermFreeze^TM (SSP)/ semen mix expands during freezing.

FAQ10: Is SpermFreeze^TM (SSP) IUI-ready? Do I need to wash the thawed semen sample before further use?
No, SpermFreeze^TM (SSP) is not IUI-ready. Thawed semen samples must be washed before further use to avoid contact of the cryopreservation medium with the uterus.

FAQ11: What should be the temperature of the thawing procedure (tap water)?
The temperature is not critical, data indicated that thawing at room temperature or 37°C does not give significantly different results.

FAQ12: Can a sample be washed or concentrated before freezing?
Ideally, cryopreservation is performed on native semen samples. In case of very low sperm concentrations it is advisable to concentrate the sperm before freezing. In case of very high sperm concentration, sperm can be diluted with FertiCult™ Flushing medium before freezing, if preferred.

FAQ13: What is the difference between SpermFreeze^TM and SpermFreeze^TM SSP?
SpermFreeze^TM SSP has a higher glycerol concentration (27% vs 15% in SpermFreeze^TM), which results in less dilution (SpermFreeze^TM requires 0.7-1ml medium for 1ml sperm, SpermFreeze^TM SSP requires 1ml medium for 3ml sperm). This reduces the number of straws per semen sample for SpermFreeze^TM SSP, but keeps the same end concentration of glycerol as SpermFreeze^TM. There is no difference in thawing procedure.