Evaluating a non-invasive test for endometrial receptivity 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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 28 Years to 45 Years |
| Sex | Female |
| Sponsor | Inti Labs Industry-sponsored |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT06544837 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with uterine cavity abnormalities or systemic diseases affecting reproductive techniques may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hanoi
- Hanoi Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Study coordinator: Tiffany Wang
- Email: tiffany@intilabs.com
- Phone: +886 3 6581031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.