Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04184323
Status:
WITHDRAWN
Last Update Posted:
2021-11-17
First Post:
2019-11-27
Brief Title:
SIRT-1 Antagonism for Endometrial Receptivity
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
SIRT1-1 Antagonist Therapy Before Embryo Transfer to Improve Endometrial Receptivity and Life Pregnancy Rates
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFER
Brief 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
Detailed Description:
The SAFER Trial will enroll women with unexplained failure after embryo transfer with euploid embryos Subjects must have existing euploid embryos for transfer and test positive for SirT1 testing on endometrial biopsy To qualify they must be 18 to 40 years of age have a normal uterine cavity no serious systemic diseases diabetes lupus cancer etc and be willing to be randomized to treatment with a SirT1 inhibitor EX-527 or placebo The medication will be provided and administered for 5 days prior to embryo transfer after progesterone therapy is begun The drug will be stopped 24 hr before embryo transfer Standard protocols will be used including administration of progesterone checking hCG 8 days after transfer ultrasound monitoring of pregnancy and pregnancy outcomes recording with Live Birth Rate LBR being the primary outcome of interest We expect to enroll 30 women with 15 subjects per arm The goal of this study is to demonstrate efficacy for a specific inhibitor of SirT1 as a primary treatment of defects in endometrial receptivity due to endometriosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None