August 15, 2006
Fertility Centers of Illinois (FCI) Offers Free Cycle of IVF Treatment Through Participation in Study of Longer-Lasting Ovary Stimulation Drug
Fertility Centers of Illinois will offer a free cycle of in-vitro fertilization (IVF) including all medications to as many as 70 patients through its participation in a clinical trial of a new long-lasting drug for ovarian stimulation. Experts are hopeful that this new drug will replace the need for daily injections for patients going through ovulation induction and IVF. FCI performs more than 2,500 IVF cycles each year.
The new drug will enable patients to receive a single injection that will last for seven days versus one injection daily. This modified drug which is a long-lasting recombinant FSH, has already been used in Europe with great success. Before the drug is approved for use in the United States, the Federal Drug and Administration (FDA) requires that a Phase III study be completed for general use among fertility patients. The study will investigate the efficacy of a long-lasting single injection of recombinant FSH to induce multiple follicles for ovarian stimulation in an IVF cycle, compared to daily recombinant FSH."FCI is excited about participating in this study as it will give us the opportunity to test the new drug and receive direct feedback from our IVF patients," says Meike Uhler, M.D., a reproductive endocrinologist with Fertility Centers of Illinois. "This study will also allow us to offer a free IVF cycle and medications, making it more affordable for patients to have the treatment." According to Dr. Uhler the average IVF cycle can cost up to $15,000.
IVF patients who meet certain criteria will need to be seen for an initial consultation by an FCI physician at one of their nine satellite offices. If accepted into the study, all monitoring during the IVF cycle must be done at FCI's River North IVF Center.
FCI cannot deviate from the following strict criteria for inclusion and exclusion in the study, which have been established by the pharmaceutical company.
Patients who will be considered as candidates for the study needs to:
-- Have an indication for IVF/ICSI
-- Be 18 - 36 years of age at the time of signing the informed consent form
-- Have a body weight of 132 lb - 198 lb and BMI of 18 - 29
-- Have normal menstrual cycle length of 24 - 35 days
-- Have ejaculatory sperm (donor semen and/or cryopreserved semen is allowed)
Patients who have the following conditions will not be considered as candidates for the study:
-- History of any endocrine abnormality other than ovulatory dysfunction
-- History of Ovarian Hyperstimulation Syndrome
-- History of PCOS
-- Antral Follicle Count greater than 20 follicles less than 11mm (both ovaries combined, measured in menstrual cycle day 2 - 5)
-- Less than 2 ovaries or any ovarian abnormality (including endometrioma greater than 10mm)
-- Presence of hydrosalpinx
-- Presence of clinically relevant pathology of the uterine cavity or fibroids greater than or equal to 5cm
-- More than 3 unsuccessful IVF cycles or recurrent miscarriage since the last established ongoing pregnancy (if applicable)
-- History of poor response to Controlled Ovarian Hyper Stimulation (COHS)
-- FSH or LH greater than 12IU/L as measured by local lab (sample taken menstrual cycle day 2 - 5)
-- Any clinically relevant abnormal lab value based on a sample taken during the screening phase
-- Recent history of epilepsy, HIV, diabetes, cardiovascular, GI, hepatic, renal or pulmonary disease
-- Abnormal karyotype of patient or partner (if performed)
-- Smoking more than 5 cigarettes day
-- History of substance abuse within 12 months prior to signing informed consent
-- Use of hormonal preparations within 1 month prior to randomization (patients may not take OCP's in cycle prior to stimulation cycle)
-- Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen of this protocol
-- Pre-Implantation Genetic Diagnosis (PGD)
Candidates interested in applying for the study should call FCI at 1.847.998.8200 and ask for Dr. Aaron Lifchez, Principal Investigator. Candidates will then be contacted by FCI.
About Fertility Centers of Illinois
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. FCI is part of IntegraMed, the nation's largest and most reputable network of fertility centers. With nearly 160 fertility specialists and scientists in 87 locations across the US, IntegraMed practices have collectively done more research in the field of reproductive medicine and treated more patients than any other physician consortium.