Study of the Aurora Test for Selecting Day 5 Embryos in ICSI Treatment Assessing Impact on Pregnancy and Live Birth Rates in Women Undergoing IVFICSI

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 embryos 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.

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