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New treatment option for Infertility Assisted Reproductive Technology
Official title A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle (Aurora-Blasto)
ClinicalTrials.gov ID: NCT07359703
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Patients undergoing ICSI treatment, with maximum 40 years of age at time of signing the ICF
- Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for fresh SET Day 5 with hCG or dual trigger (hCG + GnRH...
- Patients undergoing a first, second, third or fourth ICSI cycle
- Women with body mass index (BMI) higher than 17 and lower than 35
- Women with regular cycles (between 24 and 35 days)
You likely can't join if
- Patients with less than 8 follicles (≥12mm) on the day of their last echo visit before OPU.
- Women with history of poor oocyte maturation in a previous cycle (\< 50% MII)
- Women with Severe Endometriosis (≥ III AFS classification) (in the ovaries and if not surgically treated)
- Patients scheduled for PGD (preimplantation genetic diagnosis of monogenic/single gene defects) and PGT-A (preimplantation genetic testing on...
- 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...
See the full eligibility criteria
- Patients undergoing ICSI treatment, with maximum 40 years of age at time of signing the ICF
- 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...
- Patients undergoing a first, second, third or fourth ICSI cycle
- Women with body mass index (BMI) higher than 17 and lower than 35
- Women with regular cycles (between 24 and 35 days)
- Non-and mild-smokers (\<10 cigarettes/day)
- AMH 1,1 ng/ml (Bologna criteria), excluding poor responders according to Bologna criteria
- Patients with fresh ejaculated semen or frozen donor semen
- Patients with less than 8 follicles (≥12mm) on the day of their last echo visit before OPU.
- Women with history of poor oocyte maturation in a previous cycle (\< 50% MII)
- Women with Severe Endometriosis (≥ III AFS classification) (in the ovaries and if not surgically treated)
- Patients scheduled for PGD (preimplantation genetic diagnosis of monogenic/single gene defects) and PGT-A (preimplantation genetic testing on aneuploidy)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.