A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle (Aurora-Blasto)

NCT07359703 | Recruiting

• 2 other identifiers: ONZ-2024-042312947
• Study Type: interventional
• Target: 1,028
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Infertility Assisted Reproductive Technology

Keywords

ART

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From enrollment to pregnancy confirmed by ultrasound or clinical evidence of at least one fetus with a detectable heartbeat between weeks 6 and 8

Other Outcomes (6)

• Ongoing Pregnancy Rate (OPR) in the experimental arms versus historical control arm

  From enrollment to pregnancy confirmed by ultrasound or clinical evidence of at least one gestational sacs with fetal heart beat between weeks 10 and 12.

• Increase LBR in the experimental arms vs. the historical control arm

  From enrollment (i.e. study start), which is directly followed by Oocyte retrieval (D0) to childbirth, approximately 9 months after the transfer of a Day 5 embryo.

• CPR, OPR and LBR

  From enrollment (i.e. study start), which is directly followed by Oocyte retrieval (D0) to childbirth, approximately 9 months after the transfer of a Day 5 embryo.

Study Arms (1)

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.

Other: Aurora-Blasto

Interventions

Aurora-Blasto OTHER

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.

Informative subjects (i.e., prospective data): patients undergoing ICSI treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fertiga, Belgium: collaborator
• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, Belgium

RECRUITING

Central Study Contacts

Dominic Stoop

CONTACT

003293321699; Dominic.Stoop@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: January 22, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

BE (1)