Infertility Assisted Reproductive TechnologyAurora-BlastoNCT07359703
A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle (Aurora-Blasto)
A study testing Aurora-Blasto in people with Infertility Assisted Reproductive Technology, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In current treatments for In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI), the creation of multiple embryos is a common practice. The decision to transfer an embryo is traditionally based on the morphological assessment by an embryologist, which, due to its nature, must be considered… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility Assisted Reproductive Technology
- What is being tested?
- Aurora-Blasto
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,028 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2025to 1 Jun 2029
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing ICSI treatment, with maximum 40 years of age at time of signing the ICF
- Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for fresh SET Day 5 with hCG or dual trigger (hCG + GnRH agonist) or Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for delayed transfer of frozen/thawed SET Day 5 after a GnRH agonist trigger, hCG or dual trigger (hCG + GnRH agonist).
- Patients undergoing a first, second, third or fourth ICSI cycle
- Women with body mass index (BMI) higher than 17 and lower than 35
- Women with regular cycles (between 24 and 35 days)
- Non-and mild-smokers (<10 cigarettes/day)
- AMH 1,1 ng/ml (Bologna criteria), excluding poor responders according to Bologna criteria
- Patients with fresh ejaculated semen or frozen donor semen
Who cannot join
- Patients with less than 8 follicles (≥12mm) on the day of their last echo visit before OPU.
- Women with history of poor oocyte maturation in a previous cycle (< 50% MII)
- Women with Severe Endometriosis (≥ III AFS classification) (in the ovaries and if not surgically treated)
- Patients scheduled for PGD (preimplantation genetic diagnosis of monogenic/single gene defects) and PGT-A (preimplantation genetic testing on aneuploidy)
- Couples where the partner has an extremely low sperm count e.g.: severe oligo-astheno-teratozoospermia (OAT) with sperm count below 100.000/ml or TESE.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent
Kathleen Wijnant, 003293323013, Kathleen.wijnant@uzgent.be
About this study
Official title: A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle
In current treatments for In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI), the creation of multiple embryos is a common practice. The decision to transfer an embryo is traditionally based on the morphological assessment by an embryologist, which, due to its nature, must be considered subjective. In certain regions, invasive embryo biopsy techniques, such as Preimplantation Genetic Testing for Aneuploidy (PGT-A), are used to detect chromosomal abnormalities and support decision-making regarding embryo transfer. However, there is a medical need to improve the outcomes of IVF/ICSI cycles through non-invasive and objective methods.
As an academic center, our goal is to investigate promising innovative methods that, if successful, can be integrated into standard care. The aim of the Aurora blastocyst study is to evaluate the effectiveness of the Aurora test in selecting five-day-old embryos for fresh or frozen embryo transfer. Additionally, the study assesses whether the use of the Aurora test results in an increase in clinical pregnancy rates and live birth rates.
Read more
The Aurora test is a non-invasive test for evaluating oocyte competence and subsequently the embryo obtained in an ICSI cycle (In Vitro Fertilization). This test is performed on cumulus cells (CC) surrounding the oocyte and uses mRNA expression profiles to evaluate the developmental potential of the oocytes. The test has been developed and validated for patients stimulated with human menopausal gonadotropins (HP-hMG), an ovulatory dose of hCG, and a single embryo transfer on day 3. The test will be performed by Fertiga nv, upon receiving patients cumulus cells.
At our center, based on earlier research, the standard care involves a single embryo transfer on day 5. In this study, embryo selection based on morphology is compared with embryo selection based on morphology and the Aurora test. Finally, this study aims to evaluate the impact of the Aurora test score on the embryologist's selection decision for transferring a five-day-old embryo for single embryo transfer, by assessing parameters such as pregnancy rates and live birth rates.
Read the detailed description
The only additional procedure involves analyzing waste material i.e. cumulus cells by Fertiga nv. RNA is extracted from the cumulus cells and analyzed using qRT-PCR. Cumulus cells iare then assigned to a score based on its RNA levels. This score, known as the Aurora test score, indicates the pregnancy potential of the associated oocyte. Using this evaluation, the embryologist will select the best embryo candidates for transfer. The embryo with the highest Aurora test score from this group will be transferred. If there is no live birth and the trial has not been concluded, the patient may consider frozen/thawed embryo transfer cycles. These consecutive frozen/thawed embryo transfer cycles will also be based on the Aurora test score.
The two experimental arms (i.e. fresh SET and frozen/thawed SET) will each include approximately 140 informative patients prospectively recruited for the study undergoing ICSI, with a day 5 blastocyst transfer chosen by embryo morphology and Aurora Test. Taking into account a dropout rate of 40%, 234 patients will be required in each experimental arm. All patients in the experimental arm need to fulfil the inclusion and exclusion criteria as detailed in the protocol. The patients signing the informed consent form (ICF) will have their Cumulus Oocyte complex (COC) numbered at oocyte pick-up (OPU), tracked individually, cumulus cells will be individually denuded and then be snap-frozen and analysed for mRNA expression using oocyte quality predictive genes and two control genes. The RNA expression analysis will be done at Fertiga's Molecular Laboratory. The lab technician/embryologist will track the individual embryos during their growth as usual and classify the embryos based on their routine morphological quality parameters. From the embryos considered for transfer i.e. based on the morphology grading, the one with the highest Aurora Test ranking will be selected for single blastocyst transfer.
The study will use two matched historical control groups, each containing 280 patients, resulting in 560 control patients treated within the last 4 years at the Department of Reproductive Medicine of Ghent University Hospital preceding the initiation of the current study (retrospective study cohort). All control patients need to fulfil all the inclusion and exclusion criteria. These control patients will be matched controls where each patient undergoing the Aurora Test will be matched with two patients that had a single embryo transfer based only on morphological grading features. The controls will be matched for stimulation protocol, transfer regime (fresh or frozen/thawed), ovulation trigger (hCG/dual trigger/GnRH agonist), age category (<31, 31-35, >35) and for number of good/top quality D5 embryos (2/ 3-4 / 5-6 / >6).
- Being tested
- Aurora-Blasto
- Keywords
- ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aurora-BlastoOther
The Department of Reproductive Medicine is initiating a clinical study to investigate a new test called the Aurora test. This test uses cells that surround the woman's egg. These cells are normally not usable, as they are separated from the egg and discarded. However, for the Aurora test, these cells are not discarded but instead used for analysis. Patients undergo standard of care treatment in addition to the Aurora-test. The Aurora test is designed to score the embryos obtained. This score indicates which embryo has the highest chance of leading to a pregnancy. After the embryologist selects the embryos for transfer, the Aurora test will determine the order of transfer. The tested embryos will receive an Aurora test score from high to low, with the highest-scoring embryos being transferred first. As a result, the Aurora test may help people become pregnant more quickly.
| Study group | Role | What they receive |
|---|---|---|
| Informative subjects (i.e., prospective data): patients undergoing ICSI treatment | Experimental | The Department of Reproductive Medicine is initiating a clinical study to investigate a new test called the Aurora test. This test uses cells that surround the woman's egg. These cells are normally not usable, as they are separated from the egg and discarded. However, for the Aurora test, these cells are not discarded but instead used for analysis.
Patients undergo standard of care treatment in addition to the Aurora-test. The Aurora test is designed to score the embryos obtained. This score indicates which embryo has the highest chance of leading to a pregnancy. After the embryologist selects the embryos for transfer, the Aurora test will determine the order of transfer. The tested embryos will receive an Aurora test score from high to low, with the highest-scoring embryos being transferred first. As a result, the Aurora test may help people become pregnant more quickly. Receives: Other: Aurora-Blasto |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst selection
The primary objective of the study is to demonstrate a significant difference between selection of blastocysts solely based on morphology versus selection of the blastocyst guided by a combination of morphology and the Aurora Test ranking. We assume that the difference between the two ranking methods will be observed in at least 30% of the patients.
Measured: At Day 5 of the embryodevelopment, which is 5 days after Oocyte retrieval and ICSI procedure (D0). The Oocyte retrieval occurs after the ICF has been signed.
Secondary outcomes (1)
Clinical Pregnancy Rate
The secondary objective is to evaluate the increase of Clinical Pregnancy Rate in the experimental arm where transfer of a single blastocyst at Day 5 is based on the Aurora Test score in combination with morphological selection compared to morphological selection alone in the historical matched control arm .
Measured: From enrollment to pregnancy confirmed by ultrasound or clinical evidence of at least one fetus with a detectable heartbeat between weeks 6 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,028 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fertiga, Belgium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359703
- Sponsor's protocol ID
- ONZ-2024-0423
- Other IDs
- 12947
- Acronym
- Aurora-Blasto
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2025
- Last updated
- 22 Jan 2026
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle
- ClinicalTrials.gov ID
- NCT07359703
- Acronym / sponsor ID
- Aurora-Blasto / ONZ-2024-0423
- Keywords
- ART
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,028 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Fertiga, Belgium
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 22 Jan 2026 (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.
In current treatments for In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI), the creation of multiple embryos is a common practice. The decision to transfer an embryo is traditionally based on the morphological assessment by an embryologist, which, due to its nature, must be considered subjective. In certain regions, invasive embryo biopsy techniques, such as Preimplantation Genetic Testing for Aneuploidy (PGT-A), are used to detect chromosomal abnormalities and support decision-making regarding embryo transfer. However, there is a medical need to improve the outcomes of IVF/ICSI cycles through non-invasive and objective methods.
As an academic center, our goal is to investigate promising innovative methods that, if successful, can be integrated into standard care. The aim of the Aurora blastocyst study is to evaluate the effectiveness of the Aurora test in selecting five-day-old embryos for fresh or frozen embryo transfer. Additionally, the study assesses whether the use of the Aurora test results in an increase in clinical pregnancy rates and live birth rates.
The Aurora test is a non-invasive test for evaluating oocyte competence and subsequently the embryo obtained in an ICSI cycle (In Vitro Fertilization). This test is performed on cumulus cells (CC) surrounding the oocyte and uses mRNA expression profiles to evaluate the developmental potential of the oocytes. The test has been developed and validated for patients stimulated with human menopausal gonadotropins (HP-hMG), an ovulatory dose of hCG, and a single embryo transfer on day 3. The test will be performed by Fertiga nv, upon receiving patients cumulus cells.
At our center, based on earlier research, the standard care involves a single embryo transfer on day 5. In this study, embryo selection based on morphology is compared with embryo selection based on morphology and the Aurora test. Finally, this study aims to evaluate the impact of the Aurora test score on the embryologist's selection decision for transferring a five-day-old embryo for single embryo transfer, by assessing parameters such as pregnancy rates and live birth rates.
Detailed description
The only additional procedure involves analyzing waste material i.e. cumulus cells by Fertiga nv. RNA is extracted from the cumulus cells and analyzed using qRT-PCR. Cumulus cells iare then assigned to a score based on its RNA levels. This score, known as the Aurora test score, indicates the pregnancy potential of the associated oocyte. Using this evaluation, the embryologist will select the best embryo candidates for transfer. The embryo with the highest Aurora test score from this group will be transferred. If there is no live birth and the trial has not been concluded, the patient may consider frozen/thawed embryo transfer cycles. These consecutive frozen/thawed embryo transfer cycles will also be based on the Aurora test score.
The two experimental arms (i.e. fresh SET and frozen/thawed SET) will each include approximately 140 informative patients prospectively recruited for the study undergoing ICSI, with a day 5 blastocyst transfer chosen by embryo morphology and Aurora Test. Taking into account a dropout rate of 40%, 234 patients will be required in each experimental arm. All patients in the experimental arm need to fulfil the inclusion and exclusion criteria as detailed in the protocol. The patients signing the informed consent form (ICF) will have their Cumulus Oocyte complex (COC) numbered at oocyte pick-up (OPU), tracked individually, cumulus cells will be individually denuded and then be snap-frozen and analysed for mRNA expression using oocyte quality predictive genes and two control genes. The RNA expression analysis will be done at Fertiga's Molecular Laboratory. The lab technician/embryologist will track the individual embryos during their growth as usual and classify the embryos based on their routine morphological quality parameters. From the embryos considered for transfer i.e. based on the morphology grading, the one with the highest Aurora Test ranking will be selected for single blastocyst transfer.
The study will use two matched historical control groups, each containing 280 patients, resulting in 560 control patients treated within the last 4 years at the Department of Reproductive Medicine of Ghent University Hospital preceding the initiation of the current study (retrospective study cohort). All control patients need to fulfil all the inclusion and exclusion criteria. These control patients will be matched controls where each patient undergoing the Aurora Test will be matched with two patients that had a single embryo transfer based only on morphological grading features. The controls will be matched for stimulation protocol, transfer regime (fresh or frozen/thawed), ovulation trigger (hCG/dual trigger/GnRH agonist), age category (<31, 31-35, >35) and for number of good/top quality D5 embryos (2/ 3-4 / 5-6 / >6).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Informative subjects (i.e., prospective data): patients undergoing ICSI treatment | Experimental | Other: Aurora-BlastoThe Department of Reproductive Medicine is initiating a clinical study to investigate a new test called the Aurora test. This test uses cells that surround the woman's egg. These cells are normally not usable, as they are separated from the egg and discarded. However, for the Aurora test, these cells are not discarded but instead used for analysis. Patients undergo standard of care treatment in addition to the Aurora-test. The Aurora test is designed to score the embryos obtained. This score indicates which embryo has the highest chance of leading to a pregnancy. After the embryologist selects the embryos for transfer, the Aurora test will determine the order of transfer. The tested embryos will receive an Aurora test score from high to low, with the highest-scoring embryos being transferred first. As a result, the Aurora test may help people become pregnant more quickly. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients undergoing ICSI treatment, with maximum 40 years of age at time of signing the ICF
- Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for fresh SET Day 5 with hCG or dual trigger (hCG + GnRH agonist) or Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for delayed transfer of frozen/thawed SET Day 5 after a GnRH agonist trigger, hCG or dual trigger (hCG + GnRH agonist).
- Patients undergoing a first, second, third or fourth ICSI cycle
- Women with body mass index (BMI) higher than 17 and lower than 35
- Women with regular cycles (between 24 and 35 days)
Key exclusion criteria (5 listed)
- Patients with less than 8 follicles (≥12mm) on the day of their last echo visit before OPU.
- Women with history of poor oocyte maturation in a previous cycle (< 50% MII)
- Women with Severe Endometriosis (≥ III AFS classification) (in the ovaries and if not surgically treated)
- Patients scheduled for PGD (preimplantation genetic diagnosis of monogenic/single gene defects) and PGT-A (preimplantation genetic testing on aneuploidy)
- Couples where the partner has an extremely low sperm count e.g.: severe oligo-astheno-teratozoospermia (OAT) with sperm count below 100.000/ml or TESE.
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 |
|---|---|---|
| Aurora-BlastoThe Department of Reproductive Medicine is initiating a clinical study to investigate a new test called the Aurora test. This test uses cells that surround the woman's egg. These cells are normally not usable, as they are separated from the egg and discarded. However, for the Aurora test, these cells are not discarded but instead used for analysis. Patients undergo standard of care treatment in addition to the Aurora-test. The Aurora test is designed to score the embryos obtained. This score indicates which embryo has the highest chance of leading to a pregnancy. After the embryologist selects the embryos for transfer, the Aurora test will determine the order of transfer. The tested embryos will receive an Aurora test score from high to low, with the highest-scoring embryos being transferred first. As a result, the Aurora test may help people become pregnant more quickly. | Other | Informative subjects (i.e., prospective data): patients undergoing ICSI treatment |
Primary outcome
Blastocyst selection
Time frame: At Day 5 of the embryodevelopment, which is 5 days after Oocyte retrieval and ICSI procedure (D0). The Oocyte retrieval occurs after the ICF has been signed.
The primary objective of the study is to demonstrate a significant difference between selection of blastocysts solely based on morphology versus selection of the blastocyst guided by a combination of morphology and the Aurora Test ranking. We assume that the difference between the two ranking methods will be observed in at least 30% of the patients.
1 secondary outcome
Clinical Pregnancy Rate
Time frame: From enrollment to pregnancy confirmed by ultrasound or clinical evidence of at least one fetus with a detectable heartbeat between weeks 6 and 8
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 22 Jan 2026.
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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 Aurora-Blasto in people with Infertility Assisted Reproductive Technology, run by University Hospital, Ghent at 1 site in Belgium.
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 8 inclusion and 5 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 22 Jan 2026. 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 Belgium. 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 Dominic Stoop (003293321699, Dominic.Stoop@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst selection (time frame: At Day 5 of the embryodevelopment, which is 5 days after Oocyte retrieval and ICSI procedure (D0). The Oocyte retrieval occurs after the ICF has been signed.). 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 22 Jan 2026.