Multi-national, Multi-center, Randomized Controlled Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 28
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Viet Nam
Hanoi Hospital
RECRUITING
Hanoi
Contact Information
Primary
Tiffany Wang
tiffany@intilabs.com
+886 3 6581031
Backup
Winter Hong
winterhong@intilabs.com
+886 3 6581031
Time Frame
Start Date: 2024-06-22
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 1000
Treatments
No_intervention: Control Group
Embryo implantation according to standard procedures
Experimental: ora Test Group
Embryo implantation according to endometrial receptivity test (ora) recommendations
Related Therapeutic Areas
Sponsors
Leads: Inti Labs

This content was sourced from clinicaltrials.gov