Infertility Clinical Trials

Find Infertility Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 traditionally based on the morphological assessment by an embryologist, which, due to its nature, must be considered subjective. In certain regions, invasive embryo biopsy techniques, such as Preimplantation Genetic Testing for Aneuploidy (PGT-A), are used to detect chromosomal abnormalities and support decision-making regarding embryo transfer. However, there is a medical need to improve the outcomes of IVF/ICSI cycles through non-invasive and objective methods. As an academic center, our goal is to investigate promising innovative methods that, if successful, can be integrated into standard care. The aim of the Aurora blastocyst study is to evaluate the effectiveness of the Aurora test in selecting five-day-old embryos for fresh or frozen embryo transfer. Additionally, the study assesses whether the use of the Aurora test results in an increase in clinical pregnancy rates and live birth rates. The Aurora test is a non-invasive test for evaluating oocyte competence and subsequently the embryo obtained in an ICSI cycle (In Vitro Fertilization). This test is performed on cumulus cells (CC) surrounding the oocyte and uses mRNA expression profiles to evaluate the developmental potential of the oocytes. The test has been developed and validated for patients stimulated with human menopausal gonadotropins (HP-hMG), an ovulatory dose of hCG, and a single embryo transfer on day 3. The test will be performed by Fertiga nv, upon receiving patients cumulus cells. At our center, based on earlier research, the standard care involves a single embryo transfer on day 5. In this study, embryo selection based on morphology is compared with embryo selection based on morphology and the Aurora test. Finally, this study aims to evaluate the impact of the Aurora test score on the embryologist's selection decision for transferring a five-day-old embryo for single embryo transfer, by assessing parameters such as pregnancy rates and live birth rates.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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 antagonist/recFSH, scheduled for delayed transfer of frozen/thawed SET Day 5 after a GnRH agonist trigger, hCG or dual trigger (hCG + GnRH agonist).

• 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

Locations
Other Locations
Belgium
Ghent University Hospital
RECRUITING
Ghent
Contact Information
Primary
Dominic Stoop
Dominic.Stoop@uzgent.be
003293321699
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 1028
Treatments
Experimental: Informative subjects (i.e., prospective data): patients undergoing ICSI treatment
The Department of Reproductive Medicine is initiating a clinical study to investigate a new test called the Aurora test. This test uses cells that surround the woman's egg. These cells are normally not usable, as they are separated from the egg and discarded. However, for the Aurora test, these cells are not discarded but instead used for analysis.~Patients undergo standard of care treatment in addition to the Aurora-test. The Aurora test is designed to score the embryos obtained. This score indicates which embryo has the highest chance of leading to a pregnancy. After the embryologist selects the embryos for transfer, the Aurora test will determine the order of transfer. The tested embryos will receive an Aurora test score from high to low, with the highest-scoring embryos being transferred first. As a result, the Aurora test may help people become pregnant more quickly.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Ghent
Collaborators: Fertiga, Belgium

This content was sourced from clinicaltrials.gov