Research at PFC
Fertility Study Opportunities
- About Research at PFC
- Current Studies at PFC
- Participating in a Research Study
- Types of Studies
- Past Studies at PFC
- Other Resources
About Research at PFC
We are committed to conducting research that will promote and advance the practice of reproductive medicine. Infertility is a field that requires continual innovation and research has made the development of most current treatment methods possible. PFC participates in fertility research studies because of our desire to provide patients with better outcomes.
Our physicians rigorously evaluate the safety, risks and benefits of all research studies. All study protocols are then carefully reviewed by an independent Institutional Review Board (IRB), whose task is to ensure there is no harm or coercion to participants. The number one objective for our patients is a healthy pregnancy and we believe that participating in research should not compromise this goal. We typically participate in studies where we feel there is a direct benefit to our patients that can be easily measured.
Participating in a Research Study
Choosing to participate in a research or "clinical" study is an important personal decision. It often can be helpful to talk to a physician, to family members, or to friends when deciding to join a study. Once a patient has reviewed the studies being conducted at PFC, the next step is to discuss a patient's eligibility with their physician and the research staff who will help identify the best fertility study for them.
Participation is completely voluntary. The details of each study are carefully explained to patients as a prospective participant. It is of primary importance that each patient understands the potential benefits and risks, and understand exactly what they are agreeing to. Only patients who have given informed consent may participate in a study. There may or may not be a direct benefit to the patient in volunteering to participate, but we make certain that we feel there is a minimal risk of harm from participation. The participant can decline to enroll or withdraw from a study at any time and their decision will not affect their care in any way.
Research Study Confidentiality
A patient's personal information is kept confidential when they participate in research. It is restricted to the research staff identified in the study protocol, the study sponsor, and the regulatory agencies responsible for monitoring the integrity of research projects. In most all cases, patients participating in clinical trials are given an identifying study number and their identity is not even seen by study sponsors or monitors. Government agencies, such as the FDA, which may or may not have regulatory jurisdiction in a clinical trial, are also not permitted to share identifiable data with any other parties. All protected Personal Health Information will be obtained and maintained in compliance with all Health Insurance Portability and Accountability Act (HIPAA) regulations. A patient's name or other identifiable information will not be used in publications or reports created from the research.
Types of Studies
The methods used to conduct research can vary from study to study. One method in which PFC participates is called randomized controlled trials. In a randomized controlled trial or 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. The study may or may not be "blinded," a situation where the patient and/or the doctor and staff do not know who is receiving the placebo and who is receiving the study treatment. 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."
Other research methods offered by PFC are laboratory-based and conducted by our embryology staff. These studies typically involve an assessment of a new technology for culturing or freezing embryos, or eggs, or may 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?
If patients interested in identifying clinical studies for a specific medical condition or other criteria, ClinicalTrials.gov is a useful registry search tool. They currently has 88,856 studies with locations in 172 countries.
For additional resources in understanding clinical research and its risks and benefits click here.
For those who are not a current PFC patient, please contact our New Patient Coordinators to make an appointment to speak with one of our physicians.