Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Window of Implantation.
- Who it may be relevant to
- Registry conditions: IVF, Window of Implantation, microRNA, Implantation. Basic parameters: 28 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Diagnostic test Window of Implantation
Determine the subject's window of implantation through testing and adjust the embryo implantation time
Primary outcome measures
- Clinical pregnancy rate [Time frame: 6 weeks after embryo transfer]
Secondary outcome measures (2)
- Ongoing pregnancy rate [Time frame: 12 weeks after embryo transfer]
- Live birth rate [Time frame: 20 weeks after embryo transfer]
Eligibility criteria
Inclusion criteria
- Experienced implantation failure with euploid or low-level mosaic (< 30%) embryos in the past two years.
- Female age 28-45 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.
Exclusion criteria
- Presence of uterine cavity abnormalities that may affect implantation, such as polyps, fibroids ≧4 cm, or hydrosalpinx
- Presence of systemic diseases that may affect reproductive techniques (e.g., autoimmune diseases)
- Body mass index (BMI) over 30 kg/m²
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Vietnam · 1 center
- Hanoi Hospital — Hanoi
Identifiers
NCT: NCT06544837 · IntiLabs