Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure

Launched by INTI LABS · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new test called ORA, which is designed to help improve the chances of pregnancy for women who have had trouble with embryo implantation during in vitro fertilization (IVF). Traditionally, doctors have used a procedure called an endometrial biopsy, which involves taking a small tissue sample from the uterus, to check when the uterus is ready for an embryo. The ORA test, however, is non-invasive and only requires a blood draw to determine the best time for embryo transfer. The goal is to see if using both the ORA test and genetic testing of embryos (known as PGT-A) together can lead to better pregnancy outcomes.

To participate in this trial, women aged 28 to 45 who have experienced implantation failure with genetically normal embryos in the past two years may be eligible. Participants will either receive the standard genetic testing or both the genetic testing and the new ORA test. Throughout the study, researchers will track pregnancy success rates, including how many women become pregnant and have live births. If you decide to take part in this trial, you will receive care based on the results of these tests, which could potentially increase your chances of a successful pregnancy.

Gender

FEMALE

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