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

RecruitingNAAges 18 Years - 40 YearsFemaleUniversity Hospital, Ghent
NCT07359703 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 select

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients undergoing ICSI treatment, with maximum 40 years of age at time of signing the ICF 2. 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). 3. Patients undergoing a first, second, third or fourth ICSI cycle 4. Women with body mass index (BMI) higher than 17 and lower than 35 5. Women with regular cycles (between 24 and 35 days) 6. Non-and mild-smokers (\<10 cigarettes/day) 7. AMH 1,1 ng/ml (Bologna criteria), excluding poor responders according to Bologna criteria 8. Patients with fresh ejaculated semen or frozen donor semen Exclusion Criteria: 1. Patients with less than 8 follicles (≥12mm) on the day of their last echo visit before OPU. 2. Women with history of poor oocyte maturation in a previous cycle (\< 50% MII) 3. Women with Severe Endometriosis (≥ III AFS classification) (in the ovaries and if not surgically treated) 4. Patients scheduled for PGD (preimplantation genetic diagnosis of monogenic/single gene defects) and PGT-A (preimplantation genetic testing on aneuploidy) 5. 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.
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What it tests

  • Aurora-Blasto
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Where

1 site
Ghent University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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