Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544837
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Multi-national Multi-center Randomized Controlled Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test Ora in Patients With Implantation Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi-national Multi-center Randomized Controlled Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test Ora in Patients With Implantation Failure
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The adjustment of the timing of embryo transfer based on the endometrial receptivity profile and transferring embryos of good quality with normal chromosomes diagnosed by Preimplantation Genetic Testing for Aneuploidy PGT-A are the two main causes to improve the success of assisted reproduction treatments ART Previously endometrial receptivity analysis was performed on women undergoing IVF treatment through an invasive endometrial tissue biopsy The aim of this study is to determine the clinical benefits of ORA a novel non-invasive endometrial receptivity test that determines the optimal time for embryo transfer through a blood draw instead of an invasive endometrial tissue biopsy It is expected to recruit 1000 couples whose embryos will be analyzed by PGT-A andor who are going to evaluate their endometrium expression profile for endometrial receptivity The patients will be randomized into two groups 1 Control group undergoing PGT-A only 2 Study group the undergoing both PGT-A and ORA ART will be performed based on the results of PGT-A andor ORA Reproductive success such as implantation rates IR pregnancy rates PR ongoing pregnancy rates OGP and live birth rates LBR will be tracked and compared
Preliminary results demonstrate that both PGT-A and ORA can contribute to reproductive success improving implantation rates in patients with implantation failure Our hypothesis suggests that PGT-A and ORA could improve the performance of ART in infertile patients
Preliminary results demonstrate that both PGT-A and ORA can contribute to reproductive success improving implantation rates in patients with implantation failure Our hypothesis suggests that PGT-A and ORA could improve the performance of ART in infertile patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None