Evaluating a non-invasive test for endometrial receptivity in patients with implantation failure
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
Run by Inti Labs · NCT06544837 · Data updated 2026-11-12
This study is testing a new blood test called the Ora test to see if it can help couples who have had trouble with embryo implantation during IVF by finding the best time for embryo transfer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 28 Years to 45 Years |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | Inti Labs Industry-sponsored |
| Locations | 1 site (Hanoi) |
| Status | Recruiting |
| Started | June 22, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2027 |
| Registry record updated | May 7, 2025 |
| Trial ID | NCT06544837 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 28-45 who have experienced implantation failure with euploid or low-level mosaic embryos in the past two years.
✕Probably not a fit
Patients with uterine cavity abnormalities or systemic diseases affecting reproductive techniques may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the clinical utility of the non-invasive Ora test, which determines the optimal timing for embryo transfer in patients experiencing implantation failure during in vitro fertilization (IVF). The study will recruit 1000 couples, randomly assigning them to either a control group receiving preimplantation genetic testing for aneuploidy (PGT-A) or a study group undergoing the Ora test. By utilizing a blood draw instead of an invasive biopsy, the trial seeks to improve the success rates of assisted reproductive treatments. The primary focus is on couples with euploid or low-level mosaic embryos who have faced previous implantation challenges.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the success rates of IVF by optimizing the timing of embryo transfers.
How similar studies have gone: While the concept of non-invasive testing is gaining traction, this specific approach using the Ora test is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hanoi Hospital
Hanoi, Vietnam Recruiting
Study contacts
- Study coordinator: Tiffany Wang
- Email: tiffany@intilabs.com
- Phone: +886 3 6581031
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.