Fertility Centers of Illinois (FCI) Seeks Women Who Want to Preserve Their Fertility Through Vitrification to Participate in Study
FCI Conducts Investigational Review Board Approved Study For Women Interested In Freezing Their Eggs
In an effort to study the impact of vitrification (the ability for a woman to freeze her eggs for later use) Fertility Centers of Illinois (FCI) will conduct one of the first studies in the nation that is approved by an Investigational Review Board (IRB). Women interested in participating in the FCI study include those who are undergoing cancer treatments such as radiation, chemotherapy or surgery that could limit reproductive potential, or women who need to defer pregnancy to later in life (past 35 years old) either because they do not have a significant other or because they made the decision to postpone pregnancy. Delaying pregnancy past the age 35 increases the risk of infertility, miscarriage, or giving birth to a genetically abnormal child.
A fertility practice that receives an IRB approval goes through a rigorous process including a review of the proposed study and a review of possible risks to patients. An IRB is an independent organization charged with the responsibility of safeguarding the rights and well-being of research participants. Informed consents from subjects in the study are documented, and subject selection is made using specific criteria as they relate to possible vulnerability to unforeseen influences. Subsequently, the IRB is required to review the process of any study it approves on a regular basis at least annually. Just recently, the IRB governing commission approved the renewal of our IRB until May 7, 2007.
FCI is the first fertility practice in the Chicago area to receive approval from an IRB for the use of egg freezing (cryopreservation) techniques in a controlled study environment where quality, informed patient care is at the forefront. “Receiving an IRB approval is significant in the evaluation of any new medical technology because it provides standards and quality control,” explains Juergen Liebermann, Ph.D. and Scientific Director, IVF Lab, River North of Fertility Centers of Illinois. “Our goal is to offer patients new solutions using only the highest standards.”
Cryopreservation or freezing of human eggs is considered a recent advanced technology to help extend human fertility. However, until recently, survival rates for thawed eggs, as well as pregnancy rates using these thawed eggs have been relatively low. The embryology team at FCI has used vitrification for over two years, which is a rapid freezing technique to help achieve higher embryo survival, and therefore higher pregnancy rates, using thawed embryos. Initial reports lead us to believe that this same technology will also allow freezing of eggs that can then be thawed and fertilized at a later date, resulting in much-improved pregnancy rates over older freezing techniques. Vitrification is the process of cryopreservation using high concentrations of cryoprotectorant with rapid freezing to solidify the cell into a glass-like state without the formation of ice crystals. Ice crystals within an egg can cause damage.
According to Aaron Lifchez, M.D. and President, Fertility Centers of Illinois, early results suggest that vitrification is the most effective way to cryopreserve eggs: “FCI routinely uses vitrification with great success for patients undergoing in-vitro fertilization (IVF) procedures who have more embryos than are required for a fresh embryo transfer. Vitrification maximizes their chances of cryopreserved embryos’ being thawed at a later date and used successfully to achieve pregnancy.”
Several recent studies reporting on the outcome of oocyte (egg) vitrification are very encouraging. A June 2003 article in the journal Fertility and Sterility reports the survival of 68.6% (325/474) of oocytes that were vitrified. Of 198 eggs that were exposed to sperm, 142 (71.7%) were fertilized and 135 (95.1%) continued to develop into viable embryos. Ultimately, 28 women had their embryos transferred into their uterus, and 7 of these women achieved a live birth. A more recent report in the same journal in January of 2006 reported that of 23 patients who vitrified their eggs (for a variety of reasons), 13 or 56.5% achieved a live birth.
Dr. Lifchez also points out the potential benefits of egg freezing and storage for patients, including:
— Women at risk for losing reproductive function as a consequence of certain types of surgery or the treatment of cancer by chemotherapy or radiation therapy.
— Women who are concerned about producing an excess number of embryos as a consequence of IVF. These women would have the opportunity to fertilize only some of their eggs during their IVF cycle, leaving the others to be vitrified and possibly thawed and fertilized at another date.
— Women who are only able to achieve pregnancy through IVF using donor eggs would have the opportunity to obtain those eggs from an egg bank in much the same way that sterile males can obtain semen from a sperm bank.
— Women who are interested in the preservation of fertility and are concerned about their “biological clock.”
“We’re in the business of helping people build their families. We are hopeful that there is good reaction to this study as we continuously explore new techniques and technologies that will provide our patients with solutions and new hopes of becoming parents,” says Dr. Lifchez.
Women interested in participating in the FCI Egg Freezing Study need to meet the following criteria:
— At the time of consent-form signing, be less than 40 years of age
— Participants should be in general good health
— Prior to admission to the study patients will have a short telephone consultation with an FCI physician to make certain that they satisfy the criteria for their initial appointment
— Prior to admission to the study all applicants will be interviewed by an FCI reproductive endocrinologist and staff psychologist
— Ovarian function will be evaluated to ensure that the applicant is likely to respond well to the medications used to stimulate the production of multiple oocytes
Women interested in participating in this study should contact Fertility Centers of Illinois for more information. Please visit http://www.fcionline.com or call 1.847.FCI.4IVF, or contact FCIResearch@integramed.com.
Fertility Centers of Illinois, S.C., is one of the nation’s leading infertility treatment practices, providing advanced reproductive endocrinology services in the Chicago area for over 25 years. FCI performs more IVF than the next nine clinics combined, over 2,500 cycles per year. FCI has more babies born than the next ten centers combined with high success rates that are recognized throughout the nation. In addition to a team of nationally recognized reproductive physicians who collaborate with each other to stay current on the latest technology and procedures, FCI patients have access to many other unique support services such as professional counseling from a licensed, Ph.D. clinical psychologist, patient advocates and innovative financial options. FCI’s multiple offices are conveniently located throughout the Chicago area.
VITRIFICATION BACKGROUNDER
Numerous studies have been reported in search of developing an ideal oocyte cryopreservation method after the first report of a successful pregnancy using a thawed oocyte in 1986. Since that time several centers around the world have reported similar success. Most of these pregnancies were achieved by a slow-freezing method. The survival of oocytes following thawing after this slow-freezing technique has been very low, as have pregnancy rates (low overall success rate of about 1% implantation per frozen egg). Therefore, there has been a pressing need to develop a more efficient way to cryopreserve oocytes. Such a protocol must reduce the damage to cells caused by ice crystal formation during the freezing process. At the present time vitrification offers the best solution to the problem. Vitrification is a very simple procedure and requires no programmable freezing equipment. In the process of vitrification an oocyte is placed in a very small volume of vitrification medium and is then cooled at an extremely rapid rate. The fast freezing eliminates the formation of ice crystals in the oocyte. Subsequent to the vitrification, the oocyte is stored in liquid nitrogen until such time as it is to be thawed and fertilized.
Vitrification protocols are starting to enter the mainstream of human Assisted Reproductive Technology (ART) and have been used successfully since 1999 with the first report of a healthy baby born from vitrified oocytes. Successful pregnancies following the use of this technology are being reported with greater frequency. To date a universal vitrification protocol has not been defined. However, research towards this end continues and will no doubt lead to higher levels of clinical efficiency as well as utilization. To date, the most impressive studies quote survival rates and fertilization rates of 68.6% (325/474) and 71.1% (142/198) respectively. In this same study pregnancy rate and implantation rate per embryo transfer were 21.4% (6/28) and 6.4% (8/125) respectively. In two more recent studies (the first published and the second unpublished) pregnancy rates have been reported as 56.5% (13 pregnancies/23 patients) and 75% (3 pregnancies/4 patients). These numbers are small, but they do hold great promise for the efficacy of this technology. To date, of the approximately 200 children born using this technology, (2/3 using slow freezing and more recently 1/3 using vitrification) only 1 congenital abnormality has been reported. Clearly, the feasibility of vitrification of human oocytes has been confirmed. It is important to note, however, that because the numbers are still very small, the American Society for Reproductive Medicine (ASRM) considers egg freezing investigational. Nevertheless, the procedure is being offered by several reputable medical practices without IRB approval and is even being promoted and advertised by a newly formed company created solely for the purpose of offering egg freezing.