Physician-scientists and researchers at Shady Grove Fertility (SGF)—the largest fertility center in the United States—presented the results of a planned interim analysis of a randomized controlled trial on 11/2/17 at the 2017 American Society for Reproductive Medicine’s (ASRM) Scientific Congress & Expo in San Antonio, TX. 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).
Shady Grove Fertility physicians witness first-hand the toll that intramuscular progesterone injections can take on their patients undergoing fertility treatments. “While many IVF centers 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 randomized control trial we have undertaken to date.”
The purpose of this three-armed study is 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 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.
To improve the reliability of the study results, all patients included in the study met the same inclusion and exclusion criteria and elected to undergo the transfer of un-biopsied, high-quality embryo(s) at the blastocyst stage.
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).
During the planned interim analysis—after data collection reached 645 cycles spread across a population of 585 study participants—researchers discovered that the use of vaginal progesterone alone resulted in a one-third decrease in ongoing pregnancy rate. These findings strongly suggested that this method of progesterone supplementation was, 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 of this arm of the study.
The research finding, specifically that using only vaginal progesterone replacement is an inferior treatment protocol, will be reported in an upcoming issue of the peer-reviewed journal, Fertility and Sterility.
Though the study has already yielded results, data collection continues. Following discontinuation of the vaginal progesterone only arm, the study continued to evaluate the other two arms: (1) injected progesterone only versus (2) vaginal progesterone supplemented with a progesterone injection once every third day. The full study results will be available late in 2018.
“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.”
About Shady Grove Fertility (SGF)
SGF is a leading fertility and IVF center of excellence with 50,000 babies born, 41 physicians and 28 locations throughout MD, PA, VA, GA, and D.C. We offer patients individualized care, innovative financial options, and pregnancy rates among the highest of all national centers. SGF is proud to be a preferred choice for referring physicians and patients. Call 1-888-761-1967 or visit ShadyGroveFertility.com.
Sarah Hudson | [email protected] | 301.545.1205
Shady Grove Fertility Marketing Team