Cryopreservation is a freezing method that allows storage of living biological material for future use. Generally, patients undergoing in vitro fertilization treatments are given strong medications to increase the number of egg-containing follicles that develop on their ovaries. In a typical stimulation, 10-20 eggs may be retrieved. If the majority of eggs become fertilized, it is likely that more embryos will be available than can be safely transferred to the uterus to start a pregnancy. In that instance, these “excess” embryos can be saved for a future treatment cycle by immersing the embryos in a liquid medium that is protective for the freezing process and placing them in sealed straws in liquid nitrogen at –212C. At this low temperature, the embryos can be cryopreserved indefinitely. In a future cycle, the uterine lining is hormonally prepared for the transfer of these embryos after thawing.

In a similar fashion, men can cryopreserve semen for their future use. The reasons for cryobanking semen include:
• Preserving semen before undergoing chemotherapy or radiation treatment for cancer. These oncology treatments have a toxic effect on semen.
• Banking surgically recovered sperm for an anticipated future IVF cycle.
• Concerns on the part of the male about producing a sample when needed on the day of the retrieval.
• Banking semen from a known donor that requires infectious disease screening at the time of semen collection and Again after a quarantine period.
• Convenience (e.g., the male partner can not be present at the time of the retrieval due to other obligations).

Infectious Disease Screening Requirement for Cryobanking

Prior to cryostorage, the American Society for Reproductive Medicine, the American Association of Tissue Banks and the Food and Drug Administration guidelines recommend, and Indiana State Law requires, that patients banking semen for future use have negative blood and urethral culture tests for infectious diseases that can harm the pregnant mother or baby resulting from the use of the cryobanked specimens. Infectious disease screening includes tests for the following pathogens:

• Human Immunodeficiency Virus (HIV) 1&2
• Human T-cell Lymphotrophic Virus (HTLV I)
• Hepatitis B (surface antigen and core antibody)
• Hepatitis C antibody
• Syphillis
• Cytomegalovirus (CMV)
• Gonorrhea
• Chlamydia

Indiana State law differentiates between married, mutually monogamous and anonymous status of “donors” of banked material. Married couples require the least testing, based on the assumption that if they are sexually active within the marriage, they are already exposed to the equivalent risks from artificial insemination. For embryo storage, similar screening recommendations are in place, in compliance with the American Association of Tissue Banks (AATB) guidelines.

Recently, the FDA has issued new requirements for infectious disease testing of individuals who wish to “donate” their gametes to another person, other than a sexually intimate partner. Married persons are exempt from FDA-required testing. Your physician and your CRBI staff can clarify which, if any of these testing requirements apply to you. CRBI offers a low-cost self pay testing panel to complete testing requirements. You can call us at 317-817-1147 for more information.

Cryopreservation of Oocytes

Cryopreservation is a freezing method which allows storage of living biological material for future use. Oocyte cryopreservation remains experimental at this time with a very low practical success rate. Although babies have been born from previously frozen unfertilized eggs, the “take-home” baby rate is well below that achievable with fresh eggs. Furthermore, no data exists regarding long-term effects to the children produced from these previously cryopreserved eggs. Studies on oocyte cryopreservation are ongoing at CRBI and may eventually become the standard of care, but current techniques are still considered experimental.

Cryopreservation of Ovarian Tissue

In some cases, for example, pediatric cancer patients, oocyte freezing may not be an option. In these instances, ovarian tissue freezing can preserve immature oocytes in the tissue for future use. Like oocyte freezing, these techniques are research protocols, not established clinical procedures and outcomes are largely unknown. CRBI is conducting IRB-approved research on ovarian freezing.