Actively Recruiting
A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle
Led by University Hospital, Ghent · Updated on 2026-01-22
1028
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
F
Fertiga, Belgium
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Aurora test, a non-invasive method aimed at improving embryo selection during In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) cycles. The study focuses on women undergoing ICSI treatment and compares embryo selection based on traditional morphology with selection that also includes the Aurora test score. The goal is to see if this new test can increase clinical pregnancy rates and live birth rates. The Aurora test analyzes mRNA expression in cumulus cells surrounding the oocyte to predict the embryo's developmental potential, offering an objective alternative to current subjective assessments. The study involves patients undergoing either fresh or frozen single embryo transfers on day 5 after fertilization. The Aurora test is conducted by analyzing cumulus cells collected during oocyte retrieval. RNA is extracted and evaluated to assign an Aurora test score to each embryo, indicating its pregnancy potential. Embryos are first selected based on morphology, then ranked by this score to determine transfer order. If no live birth occurs and the trial is ongoing, frozen embryo transfer cycles will also use the Aurora test for selection. The study includes a prospective group and two matched historical control groups for comparison. Participants will have their cumulus cells collected and analyzed, with embryo development tracked by embryologists based on morphology and Aurora test scores. Outcomes measured include blastocyst selection at day 5, clinical pregnancy rates confirmed by ultrasound, and live birth rates. Patient eligibility, embryo development, and transfer outcomes will be monitored throughout the study, with data compared against historical controls. The total participation duration depends on treatment cycles and pregnancy outcomes, with follow-up extending through frozen embryo transfers if applicable.
CONDITIONS
Brief Title
A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle (Aurora-Blasto)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing ICSI treatment up to 40 years old at time of informed consent
- Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for fresh or frozen/thawed single embryo transfer on day 5
- Patients undergoing their first to fourth ICSI cycle
- Women with body mass index (BMI) between 17 and 35
- Women with regular menstrual cycles between 24 and 35 days
- Non-smokers or mild smokers (<10 cigarettes/day)
- AMH level of at least 1.1 ng/ml, excluding poor responders
- Patients using fresh ejaculated semen or frozen donor semen
You will not qualify if you...
- Patients with fewer than 8 follicles (≥12mm) on last ultrasound before oocyte retrieval
- Women with a history of poor oocyte maturation (<50% mature oocytes) in previous cycles
- Women with severe endometriosis (≥ stage III AFS classification) untreated surgically
- Patients scheduled for preimplantation genetic diagnosis (PGD) or aneuploidy testing (PGT-A)
- Couples where the male partner has extremely low sperm count, such as severe oligo-astheno-teratozoospermia with sperm count below 100,000/ml or requiring TESE
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From oocyte retrieval through day 5 blastocyst transfer and any subsequent frozen/thawed embryo transfer cycles if applicable
Participants undergo standard ICSI treatment with blastocyst transfer. Cumulus cells are collected at oocyte retrieval and analyzed using the Aurora test to score embryos. The embryologist selects the embryo with the highest Aurora test score for transfer. If there is no live birth, participants may undergo additional frozen/thawed embryo transfer cycles based on the Aurora test score.
1 oocyte retrieval visit, 1 blastocyst transfer visit, and additional visits for frozen/thawed transfers if needed
Duration - Up to 8 weeks after embryo transfer
Participants are monitored for pregnancy and clinical outcomes with ultrasound confirmation between weeks 6 and 8.
1 to 2 visits for pregnancy confirmation
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium
Actively Recruiting
Research Team
D
Dominic Stoop
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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