SIRT-1 Antagonism for Endometrial Receptivity
Reason given: Lack of funding
Key facts
- Where
- Winston-Salem, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Wake Forest School of MedicineWinston-Salem, United StatesNo longer taking part
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT04184323
- Record updated
- 17 November 2021
- Original description
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.Read full original descriptionShow less
SIRT1-1 Antagonist Therapy Before Embryo Transfer to Improve Endometrial Receptivity and Life Pregnancy Rates
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.
Inclusion: 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: systemic illness affecting kidneys or liver; chronic headache or severe migraine; Endometritis, hydrosalpinges, and known adenomyosis; Uterine septum, uterine fibroids, endometrial polyps.