Efficacy of a 3D Printed Device to facilitate Intracytoplasmic Sperm Injection (ICSI): Achieving Comparable Fertilisation Rates to Conventional Methods

This clinical investigation aims to evaluate the performance and safety of the microICSI device, an investigational product designed to improve the specialised in vitro fertilization (IVF) process of intracytoplasmic sperm injection (ICSI) by reducing physical trauma to oocytes during insemination. The microICSI device is comprised of a square dish base with angled corners, an insert and a lid. The dish size is 65.00 mm x 65.00 mm. The microICSI device with be used by experienced embryologists in a clinical setting. Full product training will be conducted prior to use. The participants will under pre-treatment and enrolment procedures, ensuring that inclusion and exclusion criteria and fully met prior to signed consent. Fresh or frozen sperm will be collected, and a minimum of six oocytes. Half the oocytes will be administered for microICSI, with the other half being used for cICSI. The clinical monitor will ensure adherence to all aspects of the trial, via clinical monitoring visits and validation of data in the EDC. If multiple oocytes progress to blastocyst stage, the best quality blastocyst will be selected for embryo transfer, as per standard best practice.