Rocky Mountain Fertility Center is conducting a pilot study to evaluate the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology to women who wish to freeze their eggs before cancer treatment, freeze their eggs to postpone child bearing and freeze excess eggs in IVF cycles rather than embryos. Your participation in the study will include a standard IVF cycle.
There will be 3 phases to the research trial
Phase 1: 15 patients will be selected to undergo a routine IVF treatment cycle and 4-8 mature oocytes will be frozen from that cycle. The remaining oocytes will undergo ICSI fertilization, creation of embryos and transfer. At the completion of this phase all of the oocytes that were frozen will be thawed fertilized with ICSI with partners frozen sperm and resultant embryos cryopreserved for future use.
Phase 2: 10 Patients will have all oocytes frozen for a brief period of time (a few hours) all oocytes will then be thawed and fertilized with ICSI. Resultant embryos will be transferred during the same cycle.
Phase 3: 5 Patients will have all oocytes frozen. Approximately 1-2 months later oocytes will be thawed, fertilized, with ICSI and transferred. The uterus will be prepared hormonally to accept the embryos.
All participants must:
- Be under the age of 36 at time of oocyte retrieval.
- Be in good general health and off all medications found to interfere with the study medications
- Desire to seek pregnancy with IVF and ICSI
- Have a normal uterine cavity confirmed by hysteroscopy or SIS at the study center with in the past 2 years
- Have normal fallopian tubes, fallopian tubes that have undergone tubal ligation, and no evidence of a hydrosalpinx by HSG.
- Have the ability to use the study medications
- Have a Day 3 FSH level less than 8.5
- Have an AMH level >1.5 9. Be a patient of RMFC
- The patient and the male partner must be free of communicable disease, with negative infectious disease screening within the past 6 months
- Be able to undergo an in office egg retrieval procedure
- Have a BMI < 35.0
Those participating in the trial will receive a significant reduction in their IVF cycle cost, for the egg freezing cycle. You, or your insurance company, will be responsible for the costs of all the medications and medical care not directly related to stimulation, removal, fertilization and freezing of your oocytes.
How much you have to pay will depend upon whether your health insurance will pay for the medications, the dose of the medications, and number of days that the medications are used, which will vary from patient to patient. However, patients are expected to save over $5000 on an IVF with ICSI treatment cycle.
Benefits to participation
Your participation may advance our understanding of how to successfully freeze and thaw ovarian tissue in a manner that may help others in need of this technology in the future. However, there is a significant possibility that there may no direct benefit to you for participation in this study.
What happens if there are an insufficient number of eggs to freeze?
During the stimulation process, those patients seen to have less than 12 good eggs developed by ultrasound will be given the option to cancel their freezing cycle and proceed at their own expense, or cancel their cycle and be billed for services rendered.
Once retrieval has occurred, the number of eggs frozen will be determined by the number of eggs retrieved for each patient. With adequate screening (young age and good egg quality tests), the majority of patients participating will stimulate and have more than 12 oocytes retrieved.
What other procedures are available to me?
You do not have to participate in this research study. You may choose not to freeze your oocytes, and undergo IVF at the full price at RMFC. For more details set up an appointment with Dr. Smith by calling 303-999-3877.