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We appreciate your interest in research opportunities at Pacific Fertility Center (PFC). As a private practice we are committed to conducting research that will promote and advance the field of reproductive medicine. We welcome your questions about potential participation in research, also known as a “clinical study”.
Our number one goal for our patients is a healthy pregnancy. All study protocols are carefully reviewed by an independent Institutional Review Board (IRB), whose task is to ensure there is no harm or undue coercion to participants. Your participation in research should not compromise the goal of a healthy pregnancy.
Choosing to participate in a clinical study is an important personal decision. It often can be helpful to talk to a physician, family members, or friends when deciding to join a study. Once you have reviewed the options of the studies being conducted at PFC, the next step is to discuss your eligibility with your physician and the study research staff. We will assist you in identifying the best clinical study option for you.
The details of each study are carefully explained to you as a prospective patient; especially the understanding that participation is voluntary. Of primary importance is that you as a patient understand the potential benefits and risks, and understand exactly what you are agreeing to. Only patients that have given informed consent may participate in a study. There may or may not be a direct benefit to you in volunteering to participate, but we make certain that we feel there is also a minimal risk of harm from participation. Infertility is a field that requires continual innovation and previous study volunteers have made most of our current treatment methods possible.
The methods used to conduct research can vary from study to study. One method that PFC participates in are called randomized controlled trials. In a randomized controlled study, the design includes two “arms” (groups) into which patients are randomly assigned. In the “control arm” patients receive current standard treatment or a placebo and in the “treatment arm” patients receive the treatment under investigation. Within the parameters of the study, it is very important that patients in the “treatment arm” are expected to be at least as successful, if not more so, than the patients in the “control arm”.
Some of the other research study methods offered by PFC are laboratory based and conducted by our embryology staff in-house. These studies typically involve an assessment of a new technology for culturing or freezing embryos, or eggs, or may occasionally involve a clinical study of a new investigational device to improve lab techniques for culturing fresh eggs or embryos. Before undertaking any such study, PFC physicians carefully consider the device or technique under investigation. Some of the preliminary questions regarding such methods include; Where does the device come from and by whom was it developed? What are the results of the preliminary studies on the device? What is the potential benefit to IVF patients? Is there any possibility that patients could fare worse in the study than patients that don’t participate?
Pacific Fertility Center carefully evaluates the risks and benefits of a study before agreeing to participate. As a general rule, we only participate in studies where we feel there is a direct benefit to our patients that can be easily measured. For example, 9 years ago we were one of the initial study sites for FDA approval of the Follistim Pen, an FSH medication delivery device that today has made fertility drug administration much easier and comfortable for patients and is now widely used for ovarian stimulation. If we strongly believe that a particular technology appears promising, we are “early adopters”; and move forward with investigating the the use of the technology.
Such was the case with vitrification (freezing technique) in 2007. We moved forward with egg and embryo vitrification at a time when the technology was new and few laboratories had adopted the process. Vitrification has been extremely successful for our patients in the 3 years it has been in use. We are not hesitant about new technology, if there are good randomized, controlled studies that prove that there is a benefit.
In laboratory based studies, the “control arm” typically involves culturing or freezing some embryos in the usual way and some embryos in the “new” or investigational way. This protocol provides a safety net and allows a meaningful comparison of old and new.
PFC participates in studies because of our desire to provide our patients with better outcomes. In the arena of fertility treatment, technology is constantly advancing, and we need to adapt as it changes. However, we do so cautiously, and with a clear focus on the risks and ultimately safety. We participate in very few studies, since most studies do not meet our standards.
If you are interested in identifying clinical studies for a specific medical condition or other criteria, ClinicalTrials.gov is a useful registry search tool. ClinicalTrials.gov currently has 88,856 studies with locations in 172 countries.
http://www.clinicaltrials.gov/
For additional resources in understanding clinical research and its risks and benefits click on the link below.
http://www.clinicaltrials.gov/ct2/info/understand
Currently, PFC has several research opportunities for which you may be eligible. If you would like further information regarding research opportunities at PFC, please ask your physician. The opportunities for which you may be eligible can be identified and discussed at your physician consult. At that time you may be connected with research personnel who can guide you through the process.
If you are not a current PFC patient, please contact our New Patient Coordinators to make an appointment to speak with one of our physicians. 415-834-3095.
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