The purpose of the oocyte cryo preservation study is to study and prove that East Coast Fertility can successfully freeze and thaw human eggs that can be used in an in vitro fertilization cycle that can result in a pregnancy and a live birth. Egg freezing will simplify and facilitate egg donation, allow patients to preserve fertility prior to undergoing ovarian removal surgery and chemotherapy as well as other potential therapies. In this study we will cryopreserve (freeze) half of your oocytes (eggs) for a few hours followed by thawing, fertilization and transfer to help you achieve a pregnancy. The other half of your oocytes are fertilized using standard IVF laboratory procedures.
Although Embryo freezing, unlike freezing eggs, has been used for many years and is proven successful to establish pregnancies, oocyte freezing is a relatively new procedure. Only a few hundred babies reportedly have been born in the world as a result of oocyte freezing.
There are a number of steps during this process which may prove unsuccessful. Oocytes may not be identified by the laboratory. Identified oocytes may not survive the freezing and thawing process, may not mature appropriately to be inseminated, may not fertilize upon insemination, may not develop into embryos for transfer, or may not establish a pregnancy.
If pregnancy is established, miscarriage may occur. Infants born after oocyte freezing may be born with birth defects or chromosome abnormalities, and it is unclear whether this risk would be higher than that seen naturally in the general population. To date no increase in birth defects has been seen from babies born as a result of oocyte cryopreservation. Although very rare, theoretically, mechanical failure may occur with the freezing equipment or storage tanks that would result in the loss of your frozen eggs.
If you choose to participate in the ooctye cryopreservation study you will be treated as a patient going through an ordinary IVF cycle, given a drug to produce multiple follicles (sacs) on your ovaries. Each follicle should have an oocyte (egg) inside. The drug, Menopur-HMG (Ferring Pharmaceuticals), is a hormone that acts on the ovary to cause development of the multiple follicles. As part of this study, Menopur will be provided by Ferring Pharmaceuticals free of charge. The nurse at the East Coast Fertility Center will teach you how to mix and inject the drug. The drug is injected with a small needle just beneath the skin (called a subcutaneous injection), and you can either give yourself the injection or have someone else give it to you. You will be monitored in the East Coast Fertility office by vaginal ultrasound exams to determine when you have developed a sufficient number of follicles. Your estrogen level will also be monitored by the center to determine when the oocytes in the follicles are mature and ready for harvest. At an appropriate time in your cycle, you will be instructed to inject yourself with HCG so oocytes can go through the final maturation process. About 35-36 hours later, the oocytes will be retrieved from the follicles by a transvaginal ultrasound-guided retrieval. For this, a needle is passed through the vagina into the follicles under ultrasound guidance, and the oocytes removed. You will be given medication through an intravenous line to sedate you during the aspiration procedure. This procedure is an outpatient procedure and you would be allowed to go home about 1- 2 hours after the retrieval. The entire time period for ovarian stimulation and oocyte retrieval would be about two weeks.
Oocytes will be identified in the Embryology Laboratory. Approximately one half of your oocytes will be frozen in a special solution. Once frozen, the oocytes will be stored in liquid nitrogen tanks for 1-3 hours. The remaining portion of your oocytes will not be frozen and will be inseminated and cultured using standard laboratory procedures.
One to three hours after freezing, your frozen oocytes will be thawed, cultured in the laboratory, injected with spouse’s sperm, examined for fertilization, and cultured for 3-7 days. The oocytes that were not frozen will be injected using standard IVF procedures, examined for fertilization, and cultured for the same 3-7 days along side the frozen/thawed oocytes.
Embryo transfer will take place on either day 3 or day 5 utilizing the embryos fertilized from the cryopreserved ooctyes. If the cryopreseved ooctyes do not survive you will have a transfer of embryos from the fresh group. Fresh and frozen oocytes will not be mixed.
All viable embryos in excess of those being transferred will be frozen for future use.
If you become pregnant after an embryo transfer as described, the study doctor will gather information about the outcome of the pregnancy as part of this research.
IVF study participants, using their own oocytes/eggs will be billed $1,350, which includes anesthesia, peri-operative and facility expenses, plus $7,500 for monitoring, laboratory, ICSI, embryo transfer, cryopreservation and retrieval expenses as well as cumulus cell co-culture and embryo glue. You will pay an additional $200-$600 for medications not provided free in this study. The first 6 months of storage are free. The fee for oocyte storage after 6 months is $50 per month ($600 per year). This fee will be waived if the eggs/embryos are thawed within one year of the date frozen. You will not be billed for the fertilization fee ($2,500), when they attempt to fertilize your own thawed oocytes. Stimulation medication in the form of Menopur-HMG will be provided by Ferring Pharmaceuticals to participants free of charge.
Patients in the IVF study may also apply for an ECF grant. Patients doing the IVF study and accepted for the grant pay $6900 including all the above services and medication and embryo storage.
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