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SRM IVF Research
Seattle Reproductive Medicine is participating in a multicenter IVF (in vitro fertilization) study sponsored by IBSA Institut Biochimique SA, makers of Fostimon®. Fostimon® is a purified FSH (Follicle Stimulation Hormone) preparation that is derived from human menopausal gonadotropins by state of the art laboratory at IBSA. IBSA is an established pharmaceutical company in Switzerland.
The purpose of this study is to compare a current FDA approved gonadotropin (Gonal-f™) to Fostimon®. Fostimon® is an approved and widely used drug in Europe. The study will assess the therapeutic efficacy, tolerance and safety of Fostimon® (study medication) compared to Gonal-f™ (approved medication) using a subcutaneous route in female patients undergoing IVF.
You may be eligible to participate in this study if you have been recommended by your physician to do IVF and have not done more than 2 prior cycles, are between the ages of 18-39, have normal uterine cavity documented by hysterosalpingogram, hysteroscopy or sonohysteroscopy within one year of screening, normal screening lab values including day 3 Follicle Stimulating Hormone and Estradiol (excluding semen analysis) and a desire to become pregnant.
You are not eligible to participate in this study if you have been pregnant 3 months prior to screening, have done 3 or more cycles of ART (assisted reproductive technologies), have had prior ART failure related to fertilization or poor response to gonadotropins, or have a body mass index greater than 30. Satellite patients are not eligible for this study unless they will be available for several extra clinic visits in Seattle.
The study protocol is similar to the standard IVF protocol used at Seattle Reproductive Medicine, but may require extra visits to complete the study protocol. The dose for Fostimon® can be changed on day 3 of Fostimon® administration. If you choose to participate, you will benefit by receiving gonadotropin medication (Fostimon® or Gonal-f™) to complete an entire IVF cycle at no charge to you. This represents approximately a $2500 value. You will be responsible for the remainder of the charges for your IVF cycle.
Both drugs (study and approved) are known to be effective at stimulating ovarian follicular development. It is hypothesized (but not proven) that Fostimon® has an equivalent potency than Gonal-f™. If this hypothesis is proven to be correct by this study then IBSA will seek FDA approval to Fostimon® in the US.
All Seattle Reproductive Medicine patients may choose standard IVF treatment and not participate in the study.
If you are interested in participating in this study, please contact:
Theresa Naluai-Cecchini, Research Coordinator at SRM at
(206) 301-5023
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