Actively Recruiting
Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
Led by Inti Labs · Updated on 2025-05-07
1000
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Experienced implantation failure with euploid or low-level mosaic (< 30%) embryos in the past two years
- Female age 28 to 45 years
- Consent to undergo a simulated cycle for non-invasive optimal implantation window testing
- Plan to undergo a frozen embryo transfer cycle
- Have at least one euploid or low-level mosaic (< 30%) frozen blastocyst
You will not qualify if you...
- Uterine cavity abnormalities affecting implantation, such as polyps, fibroids 64 cm, or hydrosalpinx
- Systemic diseases affecting reproductive techniques, e.g., autoimmune diseases
- Body mass index (BMI) over 30 kg/m6
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hanoi Hospital
Hanoi, Vietnam
Actively Recruiting
Research Team
T
Tiffany Wang
CONTACT
W
Winter Hong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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