Implementation of air quality control in reproductive laboratories in full compliance with the Brazilian Cells and Germinative Tissue Directive

Abstract

This article describes how Androfert complied with the Brazilian Cells and Germinative Tissue Directive with regard to air quality standards and presents retrospective data of intracytoplasmic sperm injection (ICSI) outcomes performed in controlled environments. An IVF facility, composed of reproductive laboratories, operating room and embryo-transfer room, was constructed according to cleanroom standards for air particles and volatile organic compounds. A total of 2060 couples requesting IVF were treated in the cleanroom facilities, and outcome measures compared with a cohort of 255 couples treated at a conventional facility from the same practice before implementation of cleanrooms. No major fluctuations were observed in the cleanroom validation measurements over the study period. Live birth rates increased (35.6% versus 25.8%; P=0.02) and miscarriage rates decreased (28.7% versus 20.0%; P=0.04) in the first triennium after cleanroom implementation. Thereafter, the proportion of high-quality embryos steadily increased whereas pregnancy outcomes after ICSI were sustained despite the increased female age and decreased number of embryos transferred. This study demonstrates the feasibility of handling human gametes and culturing embryos in full compliance with the Brazilian directive on air quality standards and suggests that performing IVF in controlled environments may optimize its outcomes. Regulatory agencies in many countries have issued directives including specific requirements for air quality standards in embryology facilities. This article describes how we complied with the Brazilian Cells and Germinative Tissue Directive with regard to air quality standards. It also presents results of IVF cycles performed in controlled environments. An IVF facility, composed of reproductive laboratories, operating room and embryo transfer room, was constructed according to cleanroom standards for air particles and volatile organic compounds. The cleanest area was the embryology laboratory, followed by the operating room and embryo transfer room. A total of 2060 couples requesting IVF were treated in the cleanroom facilities, and outcome measures compared with a cohort of 255 couples treated at a conventional facility. Live birth rates increased by 37% and miscarriage rates decreased by 30% in the first triennium after cleanroom implementation. Thereafter, the proportion of high-quality embryos steadily increased whereas pregnancy outcomes after ICSI were sustained despite the increased female age and decreased number of embryos transferred. We demonstrate the feasibility of handling human gametes and culturing embryos in full compliance with the Brazilian Directive on air quality standards and suggest that performing IVF in controlled environments may optimize its outcomes.

Relationship between biochemical, environmental, and microbiological changes with the success rate of fertilization techniques

“…Among these factors, the high relative humidity is one of the most important, because it allows the increase of popu- lations of mites and mold growth on damp surfaces. A study by Esteves (2013) (1994), cites Legionella sp, Clostridium sp, Nocardia sp relate to the transmission of infection caused by air conditioning. As to fungal contamination, Aspergillus sp is the most important (nolard, 1994;Berneteix, 1998).…”

“…The Assisted Human Reproduction (AHR) is basically a human intervention in the natural process of procreation, with the aim of enabling women with problems of infertility and sterility to satisfy the desire to achieve motherhood (Esteves, 2013). The success rate for the evaluation of the results of the techniques of RHA implies the occurrence of pregnancy with a live, healthy child (Tonguc et al, 2010).…”

“…With the introduction of the concept of clean room that reality has changed. However, few studies have reported the correlation between the levels of toxic (bacteria, dust, particulates and volatile compounds) and a decrease in the development of embryos (Esteves, 2013;Boone et al, 1994). Gametes and human embryos cultured in vitro are extremely -re, contaminants and physical trauma.…”

“…Gametes and human embryos cultured in vitro are extremely -re, contaminants and physical trauma. Several studies suggest that toxic agents, bacteria, particles, dust and chemicals (VOCs), can affect the fertilization and embryo development (Esteves, 2013;RDC23, 2011;Martinez-Hurtado et al, 2010;International Organization for Standardization, 2009;Berneteix, 1998;nolard, 1994). Lacerda (2000) reports that this mechanism, together with the accumulation of 90% of recycled air, causes an increase in the number of microorganisms in order 1000-100000 times higher compared to the external environment.…”

“…Lacerda (2000) reports that this mechanism, together with the accumulation of 90% of recycled air, causes an increase in the number of microorganisms in order 1000-100000 times higher compared to the external environment. An increase of 1g/m³ respirable particles cause an increase in respiratory diseases in 3%, impaired lung function, leading to mortality (Esteves, 2013). This review aims to condense information available about the interference of biochemical, environmental and microbiological changes in the success of the assisted reproductive technique.…”