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

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

This will test whether the Aurora test (RNA analysis of the egg's surrounding cumulus cells) helps pick the best day‑5 embryo for women up to 40 having ICSI with fresh or frozen single blastocyst transfer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1028 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: University Hospital, Ghent (Academic / other)
• Locations: 1 site (Ghent)
• Trial ID: NCT07359703 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women up to 40 years old undergoing ICSI who plan a day‑5 single blastocyst transfer, have adequate ovarian reserve (AMH of at least 1.1 ng/ml), BMI 17–35, regular cycles, and are non‑ or mild smokers are the intended candidates.

Not a fit: Women with poor ovarian response (AMH below 1.1 ng/ml or fewer than eight follicles ≥12 mm), those older than 40, heavy smokers, or those not planning a day‑5 single embryo transfer are unlikely to benefit.

Why it matters

Potential benefit: If successful, the Aurora test could improve embryo selection and increase the chance of pregnancy and live birth without invasive embryo biopsy.

How similar studies have performed: Small observational and pilot studies of cumulus cell gene expression and other non‑invasive markers have shown promising correlations with embryo competence, but large randomized evidence is limited.

Eligibility criteria

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 this trial is running

Ghent

• Ghent University Hospital — Ghent, Belgium (Recruiting)

Study contacts

• Study coordinator: Dominic Stoop

Conditions Infertility Assisted Reproductive Technology; ART