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Understanding Clinical Research

Dr. Robert F. Casper, MD, FRCSC, REI, Scientific Director, TRIO

In fertility medicine, clinical research projects deal directly with improving both the patient experience and clinical outcomes. For example, our projects may deal with improving such procedures as stimulation protocols, egg quality, and endometrial receptivity for improved implantation.

At TRIO, our clinical research has given us an international reputation, and fertility specialists worldwide look to our team to conduct research that is aimed at improving the practise of IVF in Canada, North America and beyond. Because all of our physicians are involved in research here at the clinic, there are a number of projects taking place here at any given time.

Right now, the clinical projects that are furthest along include our dual trigger study for IVF. This involves the standard hCG trigger as well as an added GnRH agonist trigger, (either Lupron or Suprefact). This research protocol increases both LH and FSH in order to simulate a natural cycle more closely. Preliminary data analysis suggests that this approach yields three more mature eggs per patient as well as an increased number of blastocysts. This research study was designed to look at 200 patient cycles to determine if the new protocol will demonstrate a significant difference in the pregnancy rate. To date, we have completed between 150 and 160 cycles. Soon, we will be starting the same clinical study — or trial — with IUI patients to determine if this protocol increases the success rate with IUI.

For clinical research to be successful, it is crucial that people volunteer to participate in a clinical trial. Here’s a brief description of how it works: preliminary data suggests that a different way of doing something is beneficial and may offer improved results. So, a clinical trial is organized to study this. There are two groups in a trial: a control group, which gets the placebo; and a study group, which gets the study protocol. Patients are randomized and cannot choose which group they are in. Studies are considered “blind” when the patient does not know which group she is in. A double blind study indicates that neither the patient nor the doctor knows who is getting the placebo and who is getting the study protocol until the code is broken at the end of the trial so that the research can be analyzed.

All research studies at TRIO are examined very strictly and approved by a third party institutional review board who assesses studies specifically for risk. Assessing studies for risk is their job. If the risk turns out to be low or negligible, the review board will likely approve it. This means that before approval, a group of independent experts has looked at the study and its design and has decided that there is zero to minimal risk for participants. If there are any minimal risks, they’ll be outlined very clearly in the subject consent form before participation. At this point, it’s up to each patient to decide if it’s an acceptable level of risk for them. Enrollment in a clinical trial at TRIO is completely voluntary.

Once a clinical trial is completed and the research is analyzed, the research finding is published in at least one and sometimes two scholarly, scientific journals. After that, the study results are validated at another clinic. If the results are reproduced, then a research protocol will become a mainstream standard-of-practise treatment.

At this point you may be asking yourself, “what is the benefit to me if I decide to participate in a clinical trial?” As a TRIO patient, you’ll be among the first to learn about and participate in our clinical trials, which give you unique access to innovative new approaches to treatment. If you are in the group that receives the actual treatment and it works, you’ll get the most direct benefit possible.

If it turns out you are in the control group, you’ll still get the same standard of care as the study group does, and down the road, in any future cycles, you’ll benefit from the improved protocols you helped to uncover. Finally, even if you don’t benefit directly, your participation will be helping other fertility patients. If you are interested in participating in a clinical trial at TRIO or would simply like more information about our projects, please speak to one of our physicians. Any of us will be pleased to discuss details and eligibility with you.