Status:

RECRUITING

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

Lead Sponsor:

University Hospital, Ghent

Collaborating Sponsors:

Fertiga, Belgium

Conditions:

Infertility Assisted Reproductive Technology

Eligibility:

FEMALE

18-40 years

Phase:

NA

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 traditi...

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 t...

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.

Key Trial Info

Start Date :

October 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2029

Estimated Enrollment :

1028 Patients enrolled

Trial Details

Trial ID

NCT07359703

Start Date

October 15 2025

End Date

June 1 2029

Last Update

January 22 2026

Active Locations (1)

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1

Ghent University Hospital

Ghent, Belgium