Required and Recommended Screening

 

First Steps For Directed Donor and Known Donors and their Recipients

Step One: Is your donor fertile? 

We recommend that every individual contemplating being a Directed Donor or Known Donor first schedule a semen analysis and test thaw appointment with TSBC prior to storing sperm.

At this appointment, the donor provides an ejaculate for evaluation only—the ejaculate is not stored and can not be used for insemination. Our lab will perform a semen analysis, freeze it, and thaw it a week later to assess cryo survival.

The semen analysis indicates the donor’s general fertility, and the test thaw indicates how well the donor’s sperm survives freezing (anywhere from 50% to 80% of sperm die in the freezing process). Based on the results, the TSBC healthworker will be able to recommend whether the donor is a good candidate for sperm banking.

If the results of the analysis and test thaw are acceptable you can move forward with the required paperwork. The initial Account Set-Up appointment is to STORE sperm. You need to be sure that your donor is fertile PRIOR to this appointment. 

Step Two: Required paperwork

Once your donor's fertility is confirmed if you would like to move forward with a storage account you must contact TSBC and have the required paperwork sent to you and the donor via email. Paperwork required for these accounts must be completed and submitted BEFORE a first appointment can be made. 

Step Three: Required medical exam

Donor must follow the instructions included in the above referenced email and get a medical exam. 

Step Four: Required first appointment and blood draw

Call and make the Account Set- Up Appointment

AT THE INITIAL VISIT THE DONOR WILL: (APPROX 2HRS)

  • Finish up some more required paperwork
  • Review and sign the Storage Contract
  • Provide a semen sample in our lab- this ejaculate will be analyzed, frozen and stored
  • Have FDA required blood and urine collected.
  • Pay initial account set-up fees

We require the following of all Directed Donors and Known Donors:

  • All initial and FDA required repeat/exit blood draws and urine testing are performed in our lab
  • A completed HIV risk assessment form
  • A personal and family health history form
  • A medical examination (which must include a genital exam for indications of sexually transmissible infections)
  • Blood testing to identify blood type and Rh factor.

We require the following of all Directed Donors:

  • An FDA required 6-month quarantine of all vials in storage
  • Exit Blood and Urine Testing
  • Desired results will release all vials

We require the following of all Known Donors

  • Repeat Blood Draws 7 days before or after each ejaculate.
  • Desired results will release vials.

Required Screening: TSBC follows FDA sperm bank regulations, which impose strict screening requirements on all donors who store semen samples in order to reduce the risk of passing on sexually transmissible infections through insemination.

Explanation of Initial Requirements

  • Medical/Physical Exam: must include a genital exam for indications of sexually transmitted diseases. This exam must have been completed no more than 3 months prior to the first storage appointment. The donor has the option of completing the exam either with his own doctor or with TSBC’s contracting physician.
  • Blood Testing: The donor has a blood draw at the first storage appointment to determine his blood type and Rh factor and to screen for the following sexually transmissible infections: HIV-1/2, HTLV-1/2, hepatitis B, hepatitis C, syphilis, and CMV.
  • Urine Testing: The donor provides a urine sample at the first storage visit  to be screened for Chlamydia and Gonorrhea.
  • CMV: Please read our page about Cytomegalovirus (CMV) for details. If the donor’s blood test results indicate being positive for CMV antibodies (many adults are), we will require that a follow-up CMV urine test to ensure that the donor is not currently infectious for CMV.
  • Genetic Testing: Please read our page about genetic testing for details on this option. TSBC does not require Directed Donors or Known Donors to have genetic testing unless the sperm is being shipped to New York State (New York Tissue Bank regulations require genetic testing of directed donors).

Exit Screening Requirements for Directed Donors Only

  • Exit Blood Draw: Directed Donor semen samples are quarantined for six months (180 days). The donor must have an exit blood draw six months after giving the final sample donation to enable the release of samples. This blood draw screens for the following sexually transmissible infections: HIV-1/2, HTLV-1/2, hepatitis B, hepatitis C, syphilis, and CMV. If the donor is positive for CMV antibodies, we also require an exit CMV urine test.
  • If storage visits extend over a period longer than three months the donor must repeat all the initial testing for sexually transmissible infections.
  • If storage visits extend over a period longer than one year, the donor must update their Personal and Family Health History form, complete another medical exam, and complete another HIV Risk Assessment form.

Repeat Screening Requirements for Known Donors

  • Known Donor semen samples are not quarantined, but it can take up to three months for the screening requirements to be completed. We do not guarantee that a Known Donor’s samples will be releasable any sooner than three months after the first storage appointment.
  • Repeat Testing and Screening: All Known Donors must complete the full STD screening described above within 7-days of each sample collected. Therefore, if a Known Donor makes multiple storage visits over longer than one week, repeat STD testing is required. A donor who donates for a period longer than 6 months must repeat the medical exam, complete a Six-Month Health Status Update, and complete a new HIV/STD risk assessment form.  Additionally, if the donor donates for over one year, they must repeat the blood chemistry panel.
  • If storage visits extend over a period longer than one year, the donor must update their Personal and Family Health History form, complete another medical exam, and complete another HIV Risk Assessment form.