Steven Young MD, PhD, and Mary Peavey MD, MSCI, both faculty in the Division of Reproductive Endocrinology and Infertility in the UNC Department of Obstetrics and Gynecology, received a five-year, $1.3 million grant from the National Institutes of Health (NIH) as part of a multi-center, prospective trial aimed at improving outcomes for women with endometriosis undergoing in vitro fertilization (IVF).
The other primary centers that will participate in this research are Yale University, Northwestern University and University of Colorado, with Hugh Taylor, MD, chair of the Department of Obstetrics and Gynecology at Yale, directing the project. UNC has participated as one of six centers in the NIH/NICHD Reproductive Medicine Network from 2013, and this grant will allow continued participation in a new version of this influential network for another five years.
Recent approval of a convenient, oral gonadotropin-releasing hormone (GnRH) antagonist for endometriosis-related pain presents a novel option for women with endometriosis who are undergoing IVF.
GnRH is a hormone responsible for the release of follicle-stimulating hormone and luteinizing hormone from the anterior lobe of the pituitary gland. GnRH antagonists directly block the GnRH receptor, decreasing estrogen exposure. There have been no previous studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility.
Young says that fertility is a common complication of endometriosis, and while IVF successfully treats many cases of endometriosis-associated infertility, pregnancy rates are diminished compared to other etiologies of infertility.
“Our long-term objectives are to better identify and treat endometriosis related infertility,” says Young. “Our central hypothesis is that, in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer, live birth rates will improve in those pretreated with GnRH antagonist compared to placebo. This method has been suggested to improve success, but prior studies using a distinct, but related approach are small, used older IVF technology, and rarely reported live birth rates.”
Endometriosis is a common disease that leads to infertility; however, optimal diagnosis and treatment of endometriosis-related infertility patients is not well-defined. With recently identified novel microRNA biomarkers that identify endometriosis, the researchers will also seek to define a powerful precision medicine approach to treatment of infertility associated with endometriosis.
In addition, the study will explore if endometriosis biomarkers predict response to GnRH antagonists and successful pregnancy in women with endometriosis. The researchers hypothesize that women with the most abnormal biomarkers at baseline will derive the most benefit from GnRH antagonist pre-treatment.
“Through this study we hope to improve identification of endometriosis in the infertile population and define a powerful precision medicine approach to treatment of the disease, which impacts more than one-in-three women with sub-fertility, but is difficult to diagnose,” says Peavey.
This research will be conducted at UNC Fertility Clinic in Brier Creek where Young and Peavey practice, and patient enrollment is expected to begin in April 2020.