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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Embryo implantation according to standard procedures | |
| ora Test Group | Experimental | Embryo implantation according to endometrial receptivity test (ora) recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Window of Implantation | Diagnostic Test | Determine the subject's window of implantation through testing and adjust the embryo implantation time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Rate of Participants with one or more intrauterine gestational sacs after 6 weeks of estimated gestational age. | 6 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Rate of Participants with fetal heartbeat after 12 weeks of gestation. | 12 weeks after embryo transfer |
| Live birth rate | Rate of Participants with live birth, defined as the delivery of a live infant with signs of life after 20 weeks of gestation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Wang | Contact | +886 3 6581031 | tiffany@intilabs.com | |
| Winter Hong | Contact | +886 3 6581031 | winterhong@intilabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Hospital | Recruiting | Hanoi | Vietnam |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2024 | Aug 5, 2024 |
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| 20 weeks after embryo transfer |
| Prot_000.pdf |