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Directed Donor Program

Directed Donor Program

Directed Donor Program

Patients that are banking as a directed or known donor must have a complete physical prior to the first banking appointment. The physical form that we provide must be completed within 7 days prior to the initial banking appointment and signed by the directed donors physician. Directed donors must also complete the medical history profile packet we will provide and bring it along with the completed physical form to their first banking appointment this must also be completed within 7 days of the initial appointment.

Patients that are banking as a directed donor or known donor are tested for the following sexually transmitted diseases at the time of their first banking appointment.

HIV 1&2 Antibody, HIV NAT, HCV NAT, HBV NAT, HTLV 1&2, Hepatitis B Sag, Hepatitis B core,

Hepatitis C Antibody, Syphilis, Gonorrhea, Chlamydia,

CMV, Blood type, West Nile Virus for banking between months 5/31-10/31

We also recommend consulting with the physician that will be utilizing the specimens to find out if there is any additional testing that he or she may require.

The specimens are then quarantined for a minimum of 6 months If the directed donor completes his banking within 7 days of his initial blood work the directed donor must be retested for many of the sexually transmitted diseases listed above prior to the release of the specimens for use. If he banked more than 1 or 2 ejaculates and his banking was completed more than 7 days from the date of his initial blood work up, all testing must be repeated per FDA guidelines.

Directed donor specimens are not represented or screened the same as International Cryogenics, Inc. anonymous donor specimens and ICI, under no circumstances will accept responsibility for any illness transmitted to the recipient, and or child or any abnormal birth defect incurred from the use of the directed donor specimens. All legal aspects of paternity, financial obligations, etc. is the responsibility of the directed donor and the recipient.

More stringent standards are required for anonymous sperm donors including a Karyotype for Chromosome analysis, Cystic Fibrosis, more extensive blood work and cultures, fertility testing, interviews and depending on the ethnic background of the donor they may also require Tay Sachs, Sickle Cell ,Thalasemia or additional genetic testing.

Procedure for banking sperm

All patients are seen at International Cryogenics, Inc. on an appointment basis only. Usually one to two days notice is all that is required to get an appointment. Initial banking appointments usually take approximately one to one & one half hours. This appointment includes a consultation to review necessary paperwork and contracts. We have the patient collect a urine specimen for the required Chlamydia & Gonorrhea testing. Next the patient collects his semen specimen. To ensure the highest quality semen specimen and for directed donations the specimen must be collected at our facility. We have very private donor rooms that are located in the back of our office. The rooms have a private living room style atmosphere. There are magazines to aid in the collection and wifi is also provided. The specimen is collected by masturbation into a sterile specimen container.

Patients then get their blood drawn for the sexually transmitted disease testing that is required by the FDA. The testing includes HIV 1&2 (AIDS Virus), HTLV 1 & 2, Hepatitis B Sag,Hepatitis B Cab, Hepatitis C,NAT HIV,HCV,HBV, Syphilis, CMV, ABO RH & type.(seasonal West Nile Virus testing is required for all banking May 31st-October 31st). The specimens must then be quarantined for a minimum of 180 days and then the directed donor must return for the required repeat STD labs. This is the testing required for use on a non-sexually intimate partner. The patient is then taken on a short tour of the lab to explain how the specimens are frozen, labeled, stored and monitored twenty four hours a day. Subsequent appointments are much shorter as the paperwork and blood is done on the 1st appointment.

A semen analysis is done on each specimen that is collected to determine the quality of the specimen. A cryo-preservative is added and the specimen is divided into small vials that are labeled with a number of identification features. The specimens are frozen and stored in liquid nitrogen (-325 F) for maximum integrity. A few drops of the specimen are frozen in a separate vial. This vial is used for the post thaw semen analysis to determine how the specimen survived the freezing process. On average 10% of the sperm will die during the freezing process. Specimens that have a lower quality before freezing may lose a higher percentage. Patients can call the next business day to get results on their specimen.

PSpecimens that are stored at a very consistent temperature, submersed in liquid nitrogen can be stored indefinitely. Storage tanks are filled with liquid nitrogen on a daily basis to insure the liquid level is above the level of the specimens at all times. The storage tanks do not run on electricity so a power outage does not affect the storage tanks in any way. We have liquid level alarms on all of our storage tanks that are monitored on a 24-hour basis.

Specimens can be shipped to physicians anywhere in the United States after all required testing and paperwork has been completed. Moving out of state does not necessitate that your frozen specimens be moved with you. Specimens can remain in storage. When you are ready to use the specimens we will ship them to a physician of your choosing. Specimens are shipped in a liquid nitrogen shipping canister. The canister keeps the specimens frozen for seven days. We ship the number of vials the physician plans to use that ovulatory cycle. If the patient's physician has a liquid nitrogen storage tank in their office we can ship as many specimens as requested. However, we don't recommend shipping all of the specimens in one shipment in the event that something would happen during the transportation.

We highly recommend that the recipient seek a fertility specialist when utilizing frozen semen specimens. Directed donors bank a limited number of specimens; it is very important that the recipient goes to a physician that can accurately determine ovulation, fertility status, etc.. Handling and thawing the specimens properly is very important to insure the highest quality specimen possible. Evaluating the quality of the frozen specimen and the fertility status of the female recipient to determine the best reproductive method needed leads to the greatest chance of success.

The man who has banked his sperm in our facility is the only one who can legally withdrawal the specimens. If he is banking the specimens for a known recipient. He will sign documents giving this recipient the right to ship and utilize the specimens after all testing and documentation is complete We require 10 days notice for the first withdrawal of your specimens. Upon receiving a written release from the directed donor, we will ship the specimens to a physician only. The directed donor is the only person that can authorize the release of his specimens. The signature on the release form must be notarized. If the directed donor changes his mind and no longer wishes for his specimens to be utilized. We will honor his request regardless of who was financially responsible for paying for the banking, lab fees and storage fees.

In the event of a directed donor's demise, ICI will be unable to release his specimens, unless they are willed to a named recipient. If the directed donor does not have a will, a signed notarized document stating his wishes to release his frozen semen specimens to a named recipient in the event of his demise will be accepted if all required testing and quarantine of the samples has been completed

ICI will not store your specimens unless all contacts are signed and witnessed by ICI on the date your initial specimen is banked.

Note: If any of the required blood tests or cultures have a positive result ICI may not be able to continue banking and the directed donor may be deemed ineligible to be a directed donor.

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