Development of a novel biocompatible pipette for cumulus–oocyte complex transfer: an experimental and functional evaluation using HSA and MEA

Abstract Background Cumulus–oocyte complex (COC) manipulation is an essential procedure in assisted reproductive technology (ART) laboratories. Conventional plastic pipettes are widely used for oocyte handling; however, material properties and surface characteristics of these devices may influence handling performance and biological compatibility. This study aimed to develop a medical-grade silicone pipette for COC manipulation and to perform preliminary biological evaluation of the fabricated device. Materials and methods A silicone-based pipette was designed and fabricated for aspiration, washing, and transfer of COCs. The developed device was evaluated using Human Sperm Assay (HSA) and Mouse Embryo Assay (MEA) as biological compatibility assessments. Sperm motility changes following exposure to the device were assessed using the Sperm Motility Index (SMI). Embryo developmental outcomes, including cleavage to the 2-cell stage and blastocyst formation, were compared between the silicone pipette and conventional pipette groups. Results Exposure to the developed silicone pipette did not demonstrate a detectable adverse effect on sperm progressive motility. The SMI values remained above the predefined acceptance threshold throughout the evaluated exposure periods. In the MEA, cleavage rates were comparable between the silicone pipette and control groups (92% vs. 94%), as were blastocyst formation rates (85% vs. 87%), with no statistically significant differences detected between groups ( P > 0.05). Conclusion The developed medical-grade silicone pipette demonstrated acceptable biological compatibility under the tested experimental conditions. The device may provide a potential alternative for COC manipulation; however, further studies involving quantitative mechanical characterization and clinical validation in human ART cycles are required before routine application.