IVFNCT06544837
Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
A study testing Window of Implantation in people with IVF and Window of Implantation, run by Inti Labs at 1 site in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Ages 28 to 45 years, women only
- Conditions the study is for
- IVF, Window of Implantation, microRNA
- What is being tested?
- Window of Implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteVietnam
- Study dates
- 22 Jun 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Hospital
Hanoi
Pham Ngoc Minh, MD, +84332368668, phamngocminh240597@gmail.com
About this study
Official title: Multi-national, Multi-center, Randomized Controlled Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
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.
- Conditions
- IVF, Window of Implantation, microRNA, Implantation, Non-invasive Testing, Endometrial Receptivity
- Being tested
- Window of Implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Window of ImplantationDiagnostic test
Determine the subject's window of implantation through testing and adjust the embryo implantation time
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Embryo implantation according to standard procedures |
| ora Test Group | Experimental | Embryo implantation according to endometrial receptivity test (ora) recommendations Receives: Diagnostic Test: Window of Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Rate of Participants with one or more intrauterine gestational sacs after 6 weeks of estimated gestational age.
Measured: 6 weeks after embryo transfer
Secondary outcomes (2)
Ongoing pregnancy rate
Rate of Participants with fetal heartbeat after 12 weeks of gestation.
Measured: 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.
Measured: 20 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start22 Jun 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inti Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544837
- Sponsor's protocol ID
- IntiLabs
- Status last verified
- Feb 2025
- First submitted
- 5 Aug 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-national, Multi-center, Randomized Controlled Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
- ClinicalTrials.gov ID
- NCT06544837
- Acronym / sponsor ID
- IntiLabs
- Conditions
- IVF, Window of Implantation, microRNA, Implantation, Non-invasive Testing, Endometrial Receptivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Inti LabsIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Embryo implantation according to standard procedures |
| ora Test Group | Experimental | Diagnostic Test: Window of ImplantationEmbryo implantation according to endometrial receptivity test (ora) recommendations |
Who may qualify
- Ages
- 28 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Window of ImplantationDetermine the subject's window of implantation through testing and adjust the embryo implantation time | Diagnostic test | ora Test Group |
Primary outcome
Clinical pregnancy rate
Time frame: 6 weeks after embryo transfer
Rate of Participants with one or more intrauterine gestational sacs after 6 weeks of estimated gestational age.
2 secondary outcomes
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
Live birth rate
Time frame: 20 weeks after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Window of Implantation in people with IVF and Window of Implantation, run by Inti Labs at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Wang (+886 3 6581031, tiffany@intilabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 6 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.