SIRT-1 Antagonism for Endometrial Receptivity

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Must test positive for SIRT1 on mid-luteal endometrial biopsy

• Prior failed embryo transfer with euploid embryos

• Have at least one euploid embryo for transfer

Exclusion Criteria:

• systemic illness affecting kidneys or liver; chronic headache or severe migraine

• Endometritis, hydrosalpinges, and known adenomyosis

• Uterine septum, uterine fibroids, endometrial polyps