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.
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
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)
Single group
Aurora-Blasto
Other interventionThe 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.
Blastocyst selection
The primary objective of the study is to demonstrate a significant difference between selection of blastocysts solely based on morphology versus selection of the blastocyst guided by a combination of morphology and the Aurora Test ranking. We assume that the difference between the two ranking methods will be observed in at least 30% of the patients.
Clinical Pregnancy Rate
The secondary objective is to evaluate the increase of Clinical Pregnancy Rate in the experimental arm where transfer of a single blastocyst at Day 5 is based on the Aurora Test score in combination with morphological selection compared to morphological selection alone in the historical matched control arm .
Ongoing Pregnancy Rate (OPR) in the experimental arms versus historical control arm
Ongoing Pregnancy Rate (OPR) in the experimental arms versus historical control arm for a Single Embryo Transfer (SET) of Day 5 embryos (while taking into account the patient stimulation (HP-hMG or rFSH ) and ovulation trigger).
Increase LBR in the experimental arms vs. the historical control arm
Increase of the Live Birth Rate (LBR) in the experimental arms versus the historical control arm for a SET of Day 5 embryos (while taking into account the patient stimulation (HP-hMG or rFSH ) and ovulation trigger).
CPR, OPR and LBR
Clinical Pregnancy Rate (CPR), OPR and LBR with respect to number of oocytes at pick-up, number of transferable embryos at Day 3, number of blastocysts at Day 5 (while taking into account the patient stimulation (HP-hMG or rFSH ) and ovulation trigger).
CPR, OPR and LBR in different age groups
CPR, OPR and LBR in age group 22-34 years, in age group 35-37 years, and in age group 38-40 years (while taking into account the patient stimulation (HP-hMG or rFSH ) and ovulation trigger).
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
Fertiga, Belgium
Collaborator
