Directed/Designated Semen Donor Program

DIRECTED/DESIGNATED SEMEN DONOR PROGRAM SERVICES

Includes the time-line for screening, testing and release of the Donor quarantined inventory

A Directed/Designated Semen Donor is anyone donating sperm for a recipient other than his spouse or intimate partner (i.e. friend, family member).

Two major factors of the Directed/Designated Semen Donor program are:

I- The Directed/Designated Semen Donor will undergo an interview, a physical examination, complete a medical/personal and family history form and a battery of blood, urine, and semen testing, prior to the actual storage of semen samples. The time interval between the laboratory testing, the physical and the processing of the initial semen sample is critical and must adhere to the FDA protocol. The time line to complete this initial evaluation is seven (7) days.

II- Cryopreserved specimen vial(s) MUST remain in quarantine for six (6) months from
the date of the last donated semen sample. The release of the cryostored semen sample(s) is contigent on the outcome of the FDA mandate laboratory testing and a secondary physical examination.

The results of the post-quarantine testing and screening must be reviewed and accepted by
The Tissue Bank's Medical Director for the Donor to be determined “Eligible” prior to the release of the inventoried specimen vial(s).

The following outline represents the process and timeline associated with the Directed/Designated Donor screening:

         A-INITIAL APPOINTMENT:

• The Directed/Designated Donor and the Client Depositor/Bailor owner/eventual recipient
  of the specimen vial(s), as well as the intimate partner or spouse, if applicable must be present
  at the initial appointment. If for any reason the Client Depositor/Bailor cannot be present at the first appointment, a phone conference interview can be held while the Directed/Designated Donor is at the Tissue Bank, however, the Tissue Bank must receive both a letter from the Client Depositor/Bailor acknowledging an understanding of the Directed/Designated Donor program, and the necessary documents to initiate storage.

• Upon completion of the registration forms, the evaluation agreement and the Donor's Medical/Personal and Family History, either the Director of The Tissue Bank or The Tissue Bank’s Supervising Cryobiologist will undertake the review of documents and interview the Directed/Designated Donor.

• The Directed/Designated Donor may collect an initial semen sample to have a semen analysis for evaluation purposes. This semen sample will be analyzed and indices will be evaluated before
  and after cryopreservation. The evaluation will include a sperm morphology assessment using
  the “Kruger” sperm differential classification. This semen sample may be retained for future use.

        B-MANDATORY INITIAL SCREENING:

• The Directed/Designated Donor must undergo the “initial laboratory testing” (‡) (listed below) within 7 days of acceptance of the first semen sample to be placed in quarantine inventory for future use:

  (‡) Testing is performed at a CLIA licensed, FDA registered laboratory using FDA cleared test kits.

Cystic Fibrosis Screening (Note that testing for Cystic Fibrosis Screening may be performed on either
the Directed/Designated Donor or the Recipient.)    

        Note: 1-The Tissue Bank recommends that the Recipient and her partner consult with their   
                 Physician and/or a Genetic Counselor as to understand the relative importance to have 
                 the Directed/Designated Donor undergo further genetic testing.

                 2- If collection of semen samples extends beyond 30 (thirty) days from the initial         

                 screening protocol, the Directed/Designated Donor will be subjected to a re-entry testing
                 protocol for the mandatory laboratory tests.

       C-FINAL TESTING ASSOCIATED WITH THE RELEASE OF CRYOSTORED SPERM VIALS:

• At the completion of the quarantine period (any time after 180 days) the Directed/Designated Donor will undergo a secondary physical exam by a physician contracted by SEBNJ, as well as,  submit  to retesting for the following laboratory tests:

       (‡) Testing is performed at a CLIA licensed, FDA registered laboratory using FDA cleared test kits.

Note:Test results must be within acceptable limits.

The cryopreserved specimen vial(s) will be released for the Recipient/Client Depositor/Bailor's use only upon the completion of all of the above tests as well as the review and signature of the Medical Director.  

Copies of all laboratory testing will be made available to the referring Physician, the Directed/Designated Donor and the Recipient/Client Depositor.          

The Directed/Designated Donor will be informed of all positive or abnormal test results.            

All communicable diseases will be reported to the appropriate State and Local Health Agencies
as specified in the New Jersey Register N.J.A.C. 8:57. 

All communications and notifications will be documented and kept as part of the
Directed/Designated Donor’s permanent record.

Diagnostic laboratory testing will be based on current requirements by regulatory agencies and the Tissue Bank. Should any governmental or regulatory agency require additional testing,
the Client Depositor/Bailor will be responsible for the completion and cost of that testing.

Contact Us:

For personalized service, to receive up to date information, obtain quotes of our fees and services or to arrange an appointment you may contact one of our Client Service Coordinators:

           within the USA:    908-232-6844 and/or 800-637-7776            

           Fax:                      908-232-2114

           for International callers: Country code +  908-232-6844 

Email: director@sperm1.com

Notice: The content of this informational site is subject to changes and modifications from time to time
to meet the requirement of various scientific and regulatory agencies.