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Donor Screening


As an FDA compliant and American Association of Tissue Banks (AATB) Inspected and Accredited semen Cryobank, CLI, which is now known as Fairfax Cryobank, Inc.- Roseville, performs testing and screening of donors in accordance with FDA and AATB Standards. In addition, we conform to the New York State Regulations and the American Society for Reproductive Medicine (ASRM) guidelines. Donor screening consists of questionnaires, blood screening, specimen screening, genetic analysis and a physical examination.

Candidates undergo vigorous, lengthy interviews involving personal questions concerning sexual behavior, family background and reasons for participating in our semen donor program. A multi-generational family history is taken and evaluated. Following extensive semen analysis, both prior to and after cryopreservation, the candidate is tested for infectious diseases. The list of screening criteria is continually being updated as regulations and standards are received from governmental and professional organizations.

After months of testing, accumulation of physical and personal data and countless interviews and discussions, the Medical Director determines the acceptability of the candidate. Upon approval of the Executive Director, Geneticist and the Medical Director, the donor applicant may participate as an active donor. Additional months of testing and screening ensue before the donor's specimens are available for use in clinical artificial insemination. After this six month period of screening and testing we feel confident and assured that the donor candidate is now ready to become an "accepted" member of the donor program.

At any time during this 6 month period of evaluation, the candidate may be rejected. Currently, CLI accepts less than 1% of those men who apply to become part of our Semen Donor Program. You may find it comforting to know that before any semen specimens are allowed out of quarantine and made available for insemination, the semen donor has had hundreds of screening tests performed. Listed below are those laboratory tests currently used for our donors.

Tests on All Donors since 8/2002

Semen Evaluation

ABO Rh Blood Typing

Infectious Disease Testing
* FDA required testing. Please note we do more than is required.
  • Neisseria gonorrhea *
  • Hepatitis B Surface Antigen *
  • Hepatitis B Core Antibody *
  • Hepatitis C Viral Antibody *
  • Cytomegalovirus (CMV) *
  • Syphilis *
  • Chlamydia *
  • HIV-1 and HIV-2 antibody *
  • HIV-1* and HIV-2 by NAT
  • HTLV-1 and HTLV-2 antibody *
  • HCV by NAT *
  • HTLV-1 and HTLV-2 by NAT
  • HSV-1 and HSV-2 (Herpes) by NAT
  • HPV (Human Papillomavirus) by NAT

Genetic Disease Testing
The FDA does not require genetic disease testing.

  • Chromosome Analysis (karyotype)
  • Cystic Fibrosis
  • Ashkenazi Jewish Ancestry - Tay Sachs, Gaucher, Canavans at a minimum
  • French Canadian Ancestry - Tay Sachs
  • Asian, Middle Eastern or Mediterranean - Thalassemia
  • African, Black American - Sickle Cell and other hemoglobinopathies

Starting June 2008:

Spinal Muscular Atrophy on all NEW donors.

Tay Sachs Disease on all Irish donors

If you have specific questions, please  contact our Client Services and we would be happy to provide test results for your preferred donors.

Additional testing may be added at any time. Specific medical or genetic testing may be available on request for an additional charge. There may be donors who entered our program prior to 8/2002 still on our current list and they will be missing some of the above mentioned tests. In addition, FDA regulations went into effect in 5/2005 and samples produced prior to that date may not have all the FDA testing completed.

Donors who do not have the 2002 screening tests listed above completed will be indicated as such on their Summary profile or their Family Medical History (if the Summary profile is not available)

For couples considering the use of donor sperm in order to prevent the recurrence of a specific genetic disease, CLI strongly recommends that prior to choosing a donor or having donor insemination, the recipient obtain genetic counseling, including guidance in selecting a donor. Please consult your physician or call us for assistance.

Semen Quality Standard for Sperm Count

See our Specimen Quality Standard

A Laboratory Report is provided with each specimen as to the expected total motile sperm count (TMC) in that specific vial.

Post Thaw ICI ( Standard) IUI (Pre-Washed) IVF Specimen
Motile Sperm Count per vial 18 million (minimum) 10 million (minimum) 5 million (minimum)

See our Must Read Before You Buy page to read common questions and answers about our Specimen Quality Standard.

 

Donor Screening and Zika Virus

Cryogenic Laboratories has revised our screening and eligibility procedure to comply with the recently released FDA guidance to prevent the transmission of the Zika virus.

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