Aurora test to select the best day-5 embryo for ICSI and blastocyst transfer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study analyzes RNA from cumulus cells collected at egg retrieval to generate an Aurora score that predicts oocyte/embryo potential using qRT‑PCR. Embryologists will use the Aurora score alongside standard morphology to select the single day‑5 blastocyst for fresh or frozen transfer. Two parallel arms (fresh single embryo transfer and frozen/thawed single embryo transfer) aim for about 140 informative patients each, with larger enrollment to allow for dropouts. Outcomes include pregnancy and live birth after the selected transfer(s), and subsequent frozen cycles will also use the Aurora score if applicable.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ghent University Hospital
  Ghent, Belgium Recruiting

Study contacts

• Study coordinator: Dominic Stoop
• Email: Dominic.Stoop@uzgent.be
• Phone: 003293321699

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.