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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-22

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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IVF Window of Implantation microRNA Implantation Non-invasive Testing Endometrial Receptivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Group

Embryo implantation according to standard procedures

Group Type NO_INTERVENTION

No interventions assigned to this group

ora Test Group

Embryo implantation according to endometrial receptivity test (ora) recommendations

Group Type EXPERIMENTAL

Window of Implantation

Intervention Type DIAGNOSTIC_TEST

Determine the subject's window of implantation through testing and adjust the embryo implantation time

Interventions

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Window of Implantation

Determine the subject's window of implantation through testing and adjust the embryo implantation time

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

28 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No