Donor Eligibility Determination and Specimen Collection

 

1. Consultation and Optional (Recommended) Semen Analysis: Call CryoGam at 800-473-9601 to schedule the Directed Donor's initial appointment. CryoGam recommends that the Directed Donor has a semen analysis prior to starting the Directed Donor process. This is not required; however, it is a good idea to find out what the sperm quality is BEFORE completion of  screening, testing, and cryopreservation.

 

2. Health History Profile: Preceding the initial appointment, the Directed Donor will need to complete a personal and family health history profile. This profile can be mailed, faxed, or e-mailed to the donor. The Directed Donor will need to complete this profile and return it to us no later than one week prior to the initial appointment. Please note that the administrative fee is due at the time of profile submission. The profile may be returned to CryoGam via e-mail, fax or mail; however, if the profile is e-mailed or faxed then the donor must bring the original completed profile to the initial appointment.

 

3. Profile Review: CryoGam will review the Directed Donor's profile and note any history that would make the donor ineligible.

 

4. Optional Consent Forms for Recipient: If the Directed Donor has a pre-determined recipient, the recipient will also need to complete consent forms before the donor's first appointment. If the Directed Donor is deemed "ineligible" based on health history provided prior to their appointment, the recipient will be notified to see if they would like to continue with the Directed Donor process.

 

5. Initial Appointment - PEI (First Physical), Bloodtest, First Specimen Collection:

 

• Read and sign consent forms and sign off specimens to the recipient (if applicable).

 

• Complete the first physical. The physical entails a complete body exam, a blood draw, and urine sample. This physical is performed by our Medical Director and is referred to as a Physical Exam-I (PE-I).

 

• Collect the first semen specimen for evaluation and cryopreservation.

 

We screen for the following in the first exam:  

• Complete semen analysis

• Blood Type and RH

• ALT

• HTLV-I and HTLV-II

• HIV-1 and HIV-2

• HIV-1 (NAT)

• Syphilis

• Nisseria gonorrhea (RPR)

• Chlamydia tracomatis

• Hepatitis B core antibody (HBcAb)

• Hepatitis B surface antigen (HbsAg)

• HBV (NAT)

• Hepatitis C antibody

• HCV (NAT)

• Cytomegalovirus (CMV) Total (IgG and IgM reflex when indicated)

• West Nile Virus (NAT) -Once between June 1st and October 31st (Beginning June 1st, 2017).

 

After CryoGam receives the donor's physical exam and test results, we will complete the initial donor eligibility determination. Please keep in mind that a reactive or positive result may deem the donor ineligible and you may be unable to proceed with that Directed Donor.

 

Additional Semen Specimen Collections and Quarantine Period

 

1. Collection Period: After the donor collects the initial semen specimen, they should schedule their next appointment.

• CryoGam recommends the donor abstain for at least 3 days but no longer than 7 days between each deposit.

• CryoGam recommends that the donor collects anywhere from 3 to 7 samples, or as many as possible. The more samples there are available the more insemination attempts can be made which will increase the chance of conception.

• We also recommend collecting as many samples as possible within the shortest amount of time within 6-months of the donor's initial physical. This "grouping" allows us to release all of the specimens that have been collected at once, after the final physical and blood draw is completed and test results are within normal.

 

2. Quarantine Period: All specimens must be quarantined for a period of 180-days (6 months) and then the donor must complete repeat screening and testing.

 

3. Repeat Screening -  Second Physical (PE-II), Bloodtest: Repeat screening and testing should be completed at least 180-days from the day the donor collected the last semen sample. It is CryoGam's policy that only specimens quarantined for 180-days prior to repeat screening and testing can be released from quarantine.

 

The PEII is typically performed by our Medical Director and is referred to as a Physical Exam-II (PE-II). The following is screened for at the Directed Donor's second physical:

 

• HTLV-I and HTLV-II

• HIV-1 and HIV-2

• HIV-1 (NAT)

• Syphilis

• Nisseria gonorrhea

• Chlamydia tracomatis

• Hepatitis B core antibody

• Hepatitis B surface antigen

• HBV (NAT)

• Hepatitis C antibody

• HCV (NAT)

• Cytomegalovirus (CMV) Total (IgG and IgM reflex when indicated)

 

4. Release of Specimens: Once we receive all the results back (and assuming the results are all negative), the specimens will be released from quarantine and may be used by the recipient. Please keep in mind that a reactive or positive result may deem the donor ineligible and you may be unable to proceed with that directed donor.

 

Genetic Testing

Genetic testing is optional for most donors completing the directed donor program. However, some states* require specific testing to be completed prior to accepting specimens from the donor. Additionally, certain ethnic origins may increase the likelihood of a donor being a carrier for some genetic conditions. It is recommended that these donors are screened for the following genetic conditions:

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Hispanic or Mexican Ancestry: San Luis Valley Syndrome (Karyotype Test)

African American Ancestry: Sickle Cell (Hemoglobin Evaluation)

Jewish, French Canadian, or Cajun Ancestry: Tay Sachs Disease (Biochemical Assay)

Greek, Italian, or Asian Ancestry: Thalassemia (Hemoglobin Evaluation)

 

The American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics (ACMG) has recommended that all reproductive tissue donors are tested for the genetic diseases listed below. Although in most cases this testing is not required*, CryoGam offers a DNA mutation analysis (Genetic Panel) to determine the donor's carrier status for these genetic diseases. Individual testing is available as well. 

 

Genetic Panel - click here for specific mutations tested

• Beta Thalassemia

• Bloom Syndrome

• Canavan Disease

• Cystic Fibrosis

• Familial Dysautonomia

• Fanconi Anemia Type C

• Gaucher Disease

• Hexosaminidase A Deficiency

• Mucolipidosis IV

• Niemann-Pick Disease, SMPD1-Associated

• Sickle Cell Disease

• Spinal Muscular Atrophy

• Tay-Sachs Disease

 

Please Note: Even if the donor has Genetic Panel testing completed, it is still recommend that donors of Hispanic, Mexican, African American, Jewish, French Canadian, Cajun, Greek, Italian, or Asian ancestry complete the corresponding biochemical assay, karyotype test or hemoglobin evaluation. 

 

*The state of New York requires all donor tissue to be screened for Cystic Fibrosis.