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Understanding Clinical Research

By Dr. Robert F. Casper, Scientific Director, TRIO

In fertility medicine, clinical research projects deal directly with improving both the patient experience and clinical outcomes. Please read on for more detailed information about clinical research at TRIO:

1. What research projects are happening right now at TRIO?

There are a number of clinical research projects taking place at TRIO at any given time that are at various stages of completion. Right now, the projects that are furthest along include our dual trigger study for IVF. This involves the standard hCG trigger as well as an added GnRHagonist 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 study with IUI patients to determine if this protocol increases the success rate with IUI.

2What is the difference between lab and medical projects?

Clinical – or medical — projects deal directly with improving both the patient experience and clinical outcomes. Our projects may deal with improving such procedures as stimulation protocols, egg quality, and endometrial receptivity for improved implantation. Whereas our Lab focuses mostly on research from a technological perspective in order to improve patient outcomes.

3Do all of your physicians have research underway?

Yes, all our physicians contribute to the research projects. If you are a TRIO patient who is interested in participating in a research project — also known as a clinical trial — please speak to any physician at TRIO for more information. (Please note that our clinical trials are only open to TRIO patients.)

4. Why is clinical research important?

In fertility medicine, clinical research is a vital aspect of improved patient outcomes. 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.

5. What does it mean for me, the patient?

As a patient at TRIO, you would receive the latest in cutting edge care: You would be among the first to learn about and participate in clinical trials, and you would have access to new protocols developed in the lab and the clinical research area.

6. Will I benefit immediately from this research?

Yes, as a TRIO patient, you would benefit immediately from our research that has been completed and has become standard of practise.

7. What is a clinical trial?

A clinical trial is a crucial component of research: it is the way researchers collect their data. In fact, there is no way to get this data unless 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 study protocol until the code is broken at the end of the trial.

8. When does research move into the mainstream standard of practise?

A 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 treatment.