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How Safe is This?

a blog by Michelle Ottey, PhD, Laboratory Director for Fairfax Cryobank, May 28, 2013

I am friends with a woman, we’ll call her Jean, whose college age daughter has recently come out and discussed the possibility of building a family using donor sperm someday. Jean loves the idea of having a grandchild and seeing her daughter happy, but had some concerns. She asked me if this was safe for her daughter, and she wanted specifics. I was happy to provide the details and thought it would be a good topic for a blog post.

In the United States Sperm Banks are under the regulation of the FDA, specifically 21 CFR Part 1271. This set of regulations is in place to ensure that Sperm Banks are screening their donors thoroughly to determine their eligibility to donate. This screening includes a physical exam and extensive infectious disease screening.

At a minimum the donors must be tested for:

  • HIV-1 Antibody
  • HIV-2 Antibody
  • Hepatitis B surface Antigen and core antibody
  • Hepatitis C Antibody
  • Cytomegalovirus (CMV) antibody
  • Syphilis (RPR)
  • HTLV I/II Antibody
  • HIV 1 NAT
  • HCV NAT
  • Chlamydia NAT
  • Gonococcus NAT

Our sperm bank does additional testing for HIV 2 NAT, HTLV I/II NAT, CMV NAT, Herpes Simplex Virus 1&2 NAT, and HPV NAT. Though not required by the FDA, most sperm banks also do genetic testing of sperm donors.

The genetic disease screening can include:

  • Chromosome Analysis (karyotype)
  • Cystic Fibrosis
  • Hemoglobin Electrophoresis/Sickle Cell
  • Spinal Muscular Atrophy (SMA)
  • Tay Sachs Disease
  • Thalassemia
  • Additional testing based on ethnic origin of the sperm donor

The genetic disease screening happens once, during the initial screening of the prospective sperm donor. The infectious disease screening and the physical exams happen at least every 180 days. Every single vial of donor sperm that is produced must remain in quarantine storage for a minimum of 180 days. The sperm donor will undergo periodic testing to “clear” those units from quarantine. This means that there is blood testing before a vial is produced and at least 180 days after that vial was produced. This gives us a window of time wherein we know the donor tested negative for infectious disease and so the sperm is safe.

We also collect extensive information about the prospective donor’s family prior to their being accepted in the program. We screen for clustering of heritable diseases. The medical profiles for all of the donors are available online, and can be used when looking for a donor. We collect updates about the medical history at every blood draw and then annually once the donor is no longer actively donating. This allows us to update the medical profile with any changes via a summary profile that is available online. Our Sperm Bank also offers a “check donor medical status” that allows you to check on the medical status of the donor at any time.

When working with a sperm bank, you should ask as many questions as you need to in order to feel comfortable with your choice of sperm donor. If you have a specific concern about a genetic condition for which you are a carrier, you should ask to speak with the Sperm Bank’s genetic counselor. FDA registered sperm banks work diligently to ensure the safety of the donor sperm that is provided.

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