As an FDA compliant and American Association of Tissue Banks (AATB) Inspected and Accredited semen Cryobank, CLI 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.
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
Here is a link to all the medical tests included on CLI 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.