UNC Fertility is proud to offer individuals and couples the opportunity to participate in our ongoing clinical trials. Clinical trials change often so please check in frequently to see if there is a study you may be eligible for. UNC is currently offering two clinical trials.
Current Trial: Pre-IVF Treatment with a GnRH Antagonist in Women with Endometriosis (PREGnant)
Recruitment is now open for the PREGnant trial at UNC Fertility. The study is for women ages 18-40 with a current diagnosis of endometriosis.
The goal of the study is to improve IVF success/live-birth rates in patients with endometriosis by pre-treating with a GnRH antagonist (Elagolix/Orlissa). Additionally, the study proposes that disease biomarkers found in the blood will identify women who will benefit most from this pre-treatment, allowing a more precise approach to treating endometriosis-related infertility.
Subjects must be ages 18-40 and have a diagnosis of endometriosis, as well as be currently undergoing or considering IVF. Other exclusion criteria for participation may apply. Contact our Research Coordinator, Tifani, at Tifani_Panek@med.unc.edu, or 773-706-4202 for more information.
Full details of the PREGnant trial can be viewed here: PREGnant Trial Details
Current Trial: The REBALANCE Study for PCOS Related Infertility
UNC Fertility is pleased to announce our participation in the REBALANCE Study, a clinical study of an investigational device, the May Health System, researching a new treatment option for women with infertility due to PCOS. We are currently seeking women with PCOS-related infertility who may be interested in participating in this study.
The objective of this study is to gather data on the effectiveness and safety of this device and procedure, called Ovarian Rebalancing™, which is intended to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS). This one-time, in-clinic procedure, done under light anesthesia, takes about an hour. The procedure uses transvaginal (via the vagina) ultrasound guidance to visualize the ovary. Once the ovary is visualized, a thin needle is inserted through the vaginal wall and into the ovary, similar to the technique routinely used for egg retrieval for IVF. Radiofrequency energy is then delivered to gently heat the surrounding ovarian tissue. The heat removes some of the ovarian tissue responsible for excess hormone production which can interfere with ovulation. After the procedure, there will be regularly scheduled blood tests, office visits, and calls occurring over 36 months (3 years). We have included a flyer that provides more information.
Patients will be randomized into two groups, one group will receive the treatment, the other will not (called a “control group”). Patients in the control group will have the option to be treated with the investigational device in the Ovarian Rebalancing procedure after three months.
If you have questions or would like to learn more, contact UNC Fertility at 919-908-0000 and if you want to learn more about May Health and the REBALANCE Study, you can visit their website at www.mayhealth.com