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D. Risk Disclaimer

Quality and Risk Disclaimer for Patients using Donor Sperm Samples

 

SxSB is licensed by the HFEA and is in full compliance with all their screening procedures. In addition to the mandatory requirements, SxSB adheres to and exceeds the donor screening and quality guidelines of the Association of Reproductive and Clinical Scientists, BFS, SaBTO and relevant EUTD guidelines for donation.

Screening:

Medical family health history and genetic testing:

  • A two generational family health history supplied by the donor is reviewed by our consultant to asses risk of potential serious hereditary disease.
  • Carrier screening for recessive disorders. To see if the donor carries a gene alteration associated with a number of diseases. If the sperm and egg provider carry an alteration in the same gene there is a reproductive risk for a child.
  • Donors screened before October 2017 – up to 4 conditions ( Cystic Fibrosis, and where indicated by genetic heritage Tay Sachs, Sickle Cell Disease and Alpha/Beta Thalassemia)
  • Donors screened after 2017: Over 176 recessive conditions or more, including those above.

Infectious disease Screening for all donors:

  • Blood screening for HIV 1&2, Hep A, Hep B, Hep C, Syphilis, HTLV 1&2 and CMV.
  • Urine screening for sexually transmitted diseases including Chlamydia and Gonorrhoea.
  • These tests are performed before donation commences, 3 months after (with viral NAAT testing for early release) and 6 months after. These tests are subject to current regulations.

Testing limitations:

There are limits to individual test sensitivity and although this is continually improved, we must allow for some deviation which is outside of SxSB control. The SxSB policy is regularly reviewed and any professional updates and / or changes to practice are immediately implemented to continue to further protect the patients using the donor sperm samples. Screening policies are available on request. We are aware that patients may believe there is no risk with using donor sperm in regard to infectious transmissible diseases and genetic problems. However, patients must understand that these risks of infection and / or inheritance of genetic disease cannot be eliminated, only greatly reduced. Our donor bank testing does not eliminate risks of transmitting disease or of the inheritance of all genetic disease. Congenital anomalies or birth defects can still occur in children conceived using donors at a frequency expected in births in the general population.

Allergic reaction:

Occasionally there can be allergic reactions to the freezing media, including antibiotics or egg yolk buffer for IUI although this risk is small and typically less than 0.5% of patients being treated.

Sperm preparation:

Human sperm is a biological sample and can vary in its ability to survive the freezing and preparation processes. Fertility centres have their own protocol for preparing sperm which can influence the final numbers available post thaw.

 

Please be aware:

  • Treatment centres have the ultimate responsibility for patient treatment options. i.e: treatment type (including ICSI conversion) and number of straws thawed and prepared.
  • SxSB guarantees a minimum of 10 million motile sperm per IUI unit. This guarantee does not apply to any other unit type, and there are no guarantees for any other unit types. 
  • Treatment centres are responsible for the preparation (after thawing) of the samples, this could include: washing, density gradient, swim-up etc.
  • Clinic procedures can and do vary greatly and can influence the final preparation and as such post prep numbers can differ.
  • Refunds will only be considered providing sufficient evidence proving minimum numbers of motile sperm have not been achieved post thaw at the patients treatment centre.

 

Any refunds or replacements will be at the discretion of SxSB after full investigations have been carried out.

 

It’s essential that clinicians providing assisted reproduction services, personally discuss with their patients the risks of using donor sperm, with suitable counselling. By signing SxSB Form J, you are confirming that you accept and understand these risks and conditions.

Please Proceed to Form E.

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