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Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure

NCT06544837 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-05-07

No results posted yet for this study

Summary

The adjustment of the timing of embryo transfer based on the endometrial receptivity profile and transferring embryo(s) 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 and/or 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 and/or 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.

Conditions

  • IVF
  • Window of Implantation
  • microRNA
  • Implantation
  • Non-invasive Testing
  • Endometrial Receptivity

Interventions

DIAGNOSTIC_TEST

Window of Implantation

Determine the subject's window of implantation through testing and adjust the embryo implantation time

Sponsors & Collaborators

  • Inti Labs

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-22
Primary Completion
2026-06-01
Completion
2027-06-01

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06544837 on ClinicalTrials.gov