Low-air-pressure clean room system: A flexible, high-quality model for assisted reproduction laboratories.

Abstract

Objective: This study aimed to develop a configurable clean room paradigm with low air pressure for assisted reproductive technology (ART) clinics and demonstrate the concept's efficacy using in vitro fertilization (IVF) treatment.

Methods: A high-standard clean room system with positive pressure (13 Pa) was built using accessible materials and equipment for ART laboratories. Methods for controlling and evaluating the clean room's characteristics were developed and implemented for quality assessment and calibration to maximize efficiency. The feasibility of the flexible clean room concept was assessed by analyzing the key performance indicators of embryo culture and IVF treatment.

Results: After 3 weeks of testing, the concentration of particles ≥0.5 μm was 6.04 times lower than the International Organization for Standardization (ISO) class 5 standard (3,520 particles/m3) in the IVF laboratory. Air pressure, noise, temperature, and humidity were controlled stably and appropriately. Five days after installation and handover, the volatile organic compound concentration dropped to 0.00 ppm. With blastocysts and a respectable blastocyst rate, embryonic culture with female patients younger than 40 matched the criteria (63.5% and 38.9%, respectively). After vitrified blastocysts were transferred, the pregnancy and implantation rates were 58.5% and 36.2%, respectively, demonstrating a high degree of treatment success.

Conclusion: Our customizable, high-quality, low-air-pressure clean room model can be implemented to achieve positive outcomes for infertility treatment.