Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
Multi-national, Multi-center, Randomized Controlled Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
1 other identifier
interventional
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2024
CompletedFirst Submitted
Initial submission to the registry
August 5, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
May 7, 2025
February 1, 2025
1.9 years
August 5, 2024
May 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Rate of Participants with one or more intrauterine gestational sacs after 6 weeks of estimated gestational age.
6 weeks after embryo transfer
Secondary Outcomes (2)
Ongoing pregnancy rate
12 weeks after embryo transfer
Live birth rate
20 weeks after embryo transfer
Study Arms (2)
Control Group
NO INTERVENTIONEmbryo implantation according to standard procedures
ora Test Group
EXPERIMENTALEmbryo implantation according to endometrial receptivity test (ora) recommendations
Interventions
Determine the subject's window of implantation through testing and adjust the embryo implantation time
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inti Labslead
Study Sites (1)
Hanoi Hospital
Hanoi, Vietnam
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2024
First Posted
August 9, 2024
Study Start
June 22, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
May 7, 2025
Record last verified: 2025-02