Important information before enrolling in a Texas Fertility Center research study
Before enrolling in a research study at TFC, it is important that you as a prospective participant fully understand the study and what your involvement would entail. In the event that either your physician or our clinical staff determines that you would be a good candidate for one of our trials, you will meet with our research coordinator, who will thoroughly discuss the goals and requirements of the study with you. As part of this process, you will be provided with an informed consent form. This document contains detailed information about the study, including the length of the study, the number of visits that you will be required to attend, and a detailed discussion of the medical procedures and medications included. It also discusses expected treatment outcomes, along with a thorough presentation of potential benefits and possible risks.
Our research coordinator will review the informed consent statement with you and answer all of your questions. If you decide to participate, after reviewing the statement and talking with staff and family members, you will need to sign the informed consent statement. Your signature indicates that you understand the study and voluntarily agree to participate.
At TFC we would never ask you to participate in a study that we feel could harm you and in fact we only participate in clinical trials that we believe should be potentially helpful. However because these are trials involving medications and/or products which are relatively new, we can’t possibly anticipate every potential outcome. For example, it is always possible that you could have an adverse response to a new medication or fail to respond favorably to a new product. This is one of the major risks of participating in a clinical trial.
Before deciding to participate, you should carefully weigh the risks described in the informed consent against any potential benefits. You may or may not receive direct benefit for yourself and your condition as a result of participating in a research study, but in any event, you will know that the knowledge developed may help others. It is important to understand that some risks are involved in clinical research, just as in routine medical care and daily life. In thinking about the risks of research, it may be helpful to focus on two things: the degree of harm that could result from taking part in a particular study, and the chance of any harm occurring. Most clinical studies pose a risk of minor discomfort, such as that associated with an injection or having your blood drawn, that lasts only a short time. On rare occasions, however, a volunteer subject may experience more significant complications that require medical attention. The specific risks associated with any research protocol are always described in detail in the informed consent document, which you will be asked to sign before taking part in research. In addition, the major risks of participating in any study will be thoroughly explained to you by a member of the research team, who will answer your questions about the study before you actually enroll.
Texas Fertility Center and Austin IVF have both been recognized for excellence in clinical research. Clinical research is an important component of educational growth at our Austin IVF center, TFC. It is also integral to our clinical practice, as we stay on the cutting edge of new developments in the field of infertility. As part of our ongoing commitment to excellence in patient care, we have been a leader in fertility research and employ a full-time dedicated research staff. We have actively participated in many industry-sponsored clinical trials evaluating the safety and efficacy of new medications, therapeutic devices, and treatment protocols for over 15 years. These studies help expand our scientific knowledge base, and allow us to be among the first practices in the United States to be able to provide new technologies to our patients. The list of previous research studies we have participated in over the years is long and varied, and may be accessed by following this link.
Participation in all clinical trials is voluntary and frequently the research grants that we receive allow our patients to undergo treatment at a markedly reduced cost. Before making a decision to participate in a clinical trial, it is important to have a basic understanding about clinical trials.
The National Institute of Health has established guidelines on treatment of study participants.
Texas Fertility Center also sponsors a significant amount of our own “in-house” research, including trials of new techniques in our IVF laboratory and in the clinical practice, as well as reviews of our extensive records of treatments and outcomes. This research has resulted in many published abstracts and papers in some of the leading journals of infertility and reproductive medicine. We have also presented many of these papers at scientific meetings including annual meetings of the American Society for Reproductive Medicine (ASRM ), the American College of Obstetrics and Gynecology (ACOG), and the Pacific Coast Reproductive Society (PCRS).
We are always looking for study participants for any study we are doing, as well as studies that might be conducted in the future. As the timing and availability of future study opportunities is uncertain, we keep a database of patients who we know are potentially interested in particular studies. To participate in one of our studies you must be a current patient of the Texas Fertility Center, so this would be the first step if you are interested.
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