At the American Society for Reproductive Medicine 2017 Scientific Congress and Expo, physician-scientists at SGF presented findings from four different studies. One study that was particularly insightful was the use of progesterone during an FET cycle. This study demonstrated that vaginal progesterone replacement alone was less effective in helping to achieve ongoing pregnancy than cycles inclusive of injected progesterone for patients undergoing a frozen embryo transfers (FET). These finding are important to international patients who are undergoing donor egg treatment to create their frozen embryos for their own FETs.
Why did SGF conduct this study?
Shady Grove Fertility physicians witness first-hand the toll that intramuscular progesterone injections can take on their patients undergoing fertility treatments. “While many IVF centres across the world use vaginal progesterone for improved patient convenience and comfort, high quality data to evaluate the effectiveness of this treatment was not available,” says Dr. Kate Devine, the Co-Director of Research at Shady Grove Fertility and a key researcher on this study. “Therefore, SGF designed and implemented this study, which represents the largest prospective randomised control trial we have undertaken to date.”
The purpose of this three-armed study was to determine whether patients could achieve similar live birth rates without daily progesterone shots. The less painful, less invasive delivery methods researchers explored in this study were progesterone replacement via vaginal suppositories, as well as supplementation through the use of a combination of suppositories and injections.
Supplemental progesterone is used in many fertility treatment protocols, as its general function is to prepare the uterus for pregnancy. For this study, researchers focused on patients administering the hormone in preparation for an FET as well as to support early pregnancy following an FET.
How is progesterone used for an FET?
When women undergoing in vitro fertilization (IVF) receive a fresh embryo transfer immediately following follicle stimulation, their progesterone levels are naturally high. During a frozen embryo transfer, on the other hand, the patient’s follicles are not stimulated immediately before implantation and therefore progesterone levels are low. To improve chances of an ongoing pregnancy and live birth, physicians need to supplement progesterone for FET patients.
About the Study
Participants were placed randomly into one of three groups. The first group used only vaginal suppositories (Endometrin® 200 mg). The second group used only intramuscular injections (50 mg progesterone in oil), and the third group used vaginal suppositories (Endometrin® 200 mg) paired with an intramuscular injection every third day (50 mg progesterone in oil).
Based on the results, researchers discovered that the use of vaginal progesterone alone resulted in a one-third decrease in ongoing pregnancy rate.
What does this mean for patients?
These findings strongly suggested that vaginal progesterone alone is, in fact, inferior to the other two treatment arms that included progesterone injections. The original intent was to continue the study until data indicating how many live births each group had achieved was available, however, once it was demonstrated that vaginal progesterone alone yielded lower ongoing pregnancy rates, investigators decided to discontinue this arm of the study.
“The hope of the SGF investigators is that if the two continuing arms demonstrate equivalent live birth rates, the study will still result in an improved experience for patients undergoing FET, by providing the option of a protocol requiring two-thirds fewer injections,” comments Devine.
Research remains one of the key pillars at SGF. It is, after all, “the only way we can understand how to provide better treatment, improved care, and get more successful results,” says Kevin S. Richter, Ph.D., Co-Director of Research for Shady Grove Fertility.
Dr. Devine echoes these sentiments, saying, “We take research as a responsibility, given our size and the amount of data that we generate, to use this data to provide better treatment for our patients.”
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