Clinical trials

Enrolled patients will undergo an Assisted Reproductive technology (ART) treatment using intracytoplasmic sperm injection (ICSI, the direct injection of a single sperm cell into an oocyte) as the method of insemination. In this prospective cohort study, patients' sperm, eggs, and embryos will be processed using an automated system called AURA (Conceivable Life Sciences), which consists of five subsystems. Specifically, sperm samples will be prepared for fertilization using the subsystem C:SPERM. Cumulus-oocyte complexes (COCs) containing the oocytes will be isolated from follicular fluid using the subsystem C:EGG. One out of every four COCs will be removed from the AURA system at random and processed according to the local treatment clinic's standard operating procedure. All other COCs will continue automated procedures and will be denuded, fertilized, incubated, and vitrified using the AURA subsystems C:EGG. C:ICSI, C:CULTURE and C:VIT, respectively. All automated procedures will be conducted under the supervision of a laboratory manager, who can intervene, address any potential anomalies, and override any steps undertaken by the automated AURA system. The study aims to deliver a descriptive evaluation of the AURA system, including assessing the device's performance, defined by its level of automation, efficiency, and throughput. As a secondary objective, the study aims to characterize the clinical performance of each of AURA's subsystems and correlate this performance against pre-established benchmarks in a non-inferiority statistical analysis. Finally, the study seeks to collect technical data related to AURA's hardware and software operation.

Purpose: This study aims to test whether a new automated system can freeze human eggs and embryos as effectively as the current manual method performed by laboratory staff. Background: Currently, freezing eggs and embryos during fertility treatments (IVF/ICSI) is done entirely by hand by skilled embryologists. This manual process is time-consuming, requires extensive training, and outcomes can vary between different staff members. Automating this process could help standardize procedures, reduce costs, and potentially make fertility treatments more accessible to patients. What is Being Tested: The study will compare an automated freezing system (prototype designation PRESERVE-CR) against the standard manual freezing method. The key research question is: Can the automated system preserve eggs and embryos as successfully as experienced embryologists do by hand? How It Works: Patients undergoing IVF/ICSI treatment at CARE Fertility Manchester who consent to participate will have their surplus eggs and embryos (those not suitable for their treatment) divided into two groups. Some will be frozen using the traditional manual method, and some using the new automated system. Both groups will then be thawed to measure survival rates. Tests do not encompass any reproductive outcomes or the creation of embryos specifically for this research. Why This Matters: If successful, automated freezing could help reduce the workload on laboratory staff, standardize the freezing process across different clinics, potentially lower treatment costs, and make fertility treatments available to more people who need them. The study only uses oocytes and embryos which are unsuitable for patient treatment and that would otherwise be discarded, ensuring no impact on participants' actual fertility treatment.