Donor Screening

All donor semen specimens offered by ReproMed are in full compliance with the Health Canada/Food and Drugs Act - Processing and Distribution of Semen for Assisted Conception Regulations, 1996, 2000; the Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination, July 2000, and the Assisted Human Reproduction (AHR) Act, 2004.

ReproMed's catalogue consists of donor semen from two sources:

• Canadian donors recruited locally, and the specimens processed in ReproMed's laboratory
• Imported specimens (from the United States) through a distribution agreement with Xytex International

Although testing and screening methods vary slightly between both sources, samples are comparable in terms of safety and quality. As the leader of sperm banking in Canada, we strongly stand behind these fundamental principles of ensuring the best product possible for our patients. Here is a breakdown of the screening process for each source of donor semen:

ReproMed Produced Samples:

A typical Testing Schedule for a Donor Candidate includes:
1.	First interview and semen analysis. Non-identifying information is obtained: donation agreements medical-genetic history donor personality profile semen analysis exclusionary criteria screening
2.	Second interview and semen analysis.
3.	Third semen analysis. Serological / virological / genetic / microbiological testing.
4.	Psychological Assessment.
5.	Fourth semen analysis and physical examination.
6.	Assessment and evaluation for acceptance or rejection.

At any time during this 6 months period of evaluation, the candidate may be rejected. ReproMed accepts less that 5% 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, ReproMed's semen donor had had 214 serology, virology, bacteriology, and semen tests performed. Listed below are the laboratory tests currently used for donors:

Test	Initial Applicant Screening	Six Monthly	Every Specimen
HIV 1/2	X	X
HTLV 1/2	X	X
HEP C ANTIBODY	X	X
HEP Bs ANTIBODY	X	X
HEP B CORE AB	X	X
HEP Bs ANTIGEN	X	X
C. TRACHOMATIS	X	X	X
N. GONORRHOEA	X	X	X
SEMEN CULTURE	X	X	X
SYPHILIS (RPR)	X	X
SYPHILIS (trep. Specific)	X	X
CMV ANTIBODY (IgG, IgM)	X	X
BLOOD GROUP + Rh factor	X
SGPT (ALT)	X	X
SEMEN WBC	X
SEMEN MORPHOLOGY	X
CMV CULTURE	X	X
HERPES SIMPLEX CULTURE	X	X
MYCOPLASMA/UREAPLASMA	X	X
MAR SCREENING	X
WEST NILE VIRUS (NAAT)	X	X
SARS/WNv CLINICAL SYMPTOM SCREENING	X	X	X
SICKLING TEST*	X
HB ELECTROPHORESIS	X
CYSTIC FIBROSIS SCREEN*	X
KARYOTYPE	X
TAY-SACHS SCREEN*	X

*Donors are tested for Cystic Fibrosis carrier status, and have less than a 1% risk of transmission. Donors belonging to a high-risk population for Tay Sachs, Sickle Cell Anemia or Thalassemia are tested for these disorders

Xytex Produced Samples:

All donors must complete a comprehensive Medical History Questionnaire (MHQ). This questionnaire includes questions regarding to the health of the donor and the donor's blood relatives. Also included are questions for high risk behaviors, questions developed by the U.S. Centers for Disease Control and Prevention (CDC). Any affirmative answer to the CDC questions automatically disqualifies a potential donor. All questionnaires are reviewed by the Xytex Medical Director.

If a donor's MHQ is acceptable, the donor is screened, but not specifically tested, for certain diseases and behaviors based on information provided to Xytex on the MHQ. The following testing is completed on all donors:

physical examination for evidence of sexually transmitted disease

initial lab testing, including:

• complete blood count
• blood typing
• HIV 1 & 2 antibody testing
• HIV/HCV NAT (as of 05-25-05)
• Hepatitis B surface antigen
• Hepatitis B core antibody testing
• Hepatitis C antibody testing
• cytomegalovirus IgG & IgM
• syphilis serology (RPR and TP-PA)
• HTLV I & II antibody screening
• full genital culture which includes testing for gonorrhea
• urine PCR testing for chlamydia and gonorrhea
• and urine testing for trichomonas

All Xytex donors have been screened for symptoms of West Nile Virus and SARS at each donation and on the medical history questionnaire. As long as the donor continues to participate in the program, he is required to repeat lab testing at a minimum of six-month intervals for HIV 1 & 2, Hepatitis B, Hepatitis C, cytomegalovirus, syphilis, HTLV I & II, gonorrhea, chlamydia and trichomonas. In accordance with the regulations of Health Canada, testing for both Chlamydia and Gonorrhea is done each time a sample is collected.

He is also required to update his medical history and to have a physical examination every six months. At this time he is asked about the occurrence of any new disease within his family. If there is a change in status, the donor's profile is updated with the new information. The questionnaire itself is updated as necessary to ensure that Xytex is in compliance with new regulations or Xytex company policies.

Genetic Testing

ReproMed strives to perform genetic testing in a thoughtful and rational manner for common and relevant diseases. ReproMed provides the following genetic testing for anonymous and Open-ID donors:

• Cystic Fibrosis
• Chromosome Analysis (karyotype)
• Hemoglobinopathies including sickle cell and thalassemia (for all Xytex donors joining the program as of 10/26/07)
• Tay Sachs (for all Xytex donors joining the program as of 4/28/08)
• Spinal Muscular Atrophy (for all new Xytex donors joining the program as of 12/10/08)
• Additional genetic testing is performed depending on the ethnic background of donors (African-American, Jewish, Mediterranean):
• Sickle Cell
• Thalassemia (alpha and beta)
• Canavan
• Gaucher
• Fanconi Anemia (Jewish)
• Familial Dysautonomia (Jewish)
• Niemann-Pick (Jewish)

Please contact ReproMed to confirm the genetic testing performed on your specific donor.