Progesterone resistance is mediated through epigenetic modification through SirT1 activation
and is thought to contribute to infertility and progression of endometriosis. Endometriosis
is a leading cause of unexplained IVF failure secondary to inflammatory changes that induce
SirT1. The current study is designed to investigate a small molecule inhibitor of SirT1, in
the clinical setting of In Vitro Fertilization and Embryo Transfer. The SAFER trial will
compare EX-527 to placebo in a randomized, double-blind trial. Primary endpoints include Live
Birth Rate (LBR) and secondary outcomes include pregnancy rate (PR), miscarriage rate (MR)
and implantation failure rate.