title: 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.
authors.affiliation: ANDROFERT, Andrology and Human Reproduction Clinic, Center for Male Reproduction, Campinas, São Paulo, Brazil. s.esteves@androfert.com.br
authors.forename: Sandro C
authors.initials: SC
authors.lastname: Esteves
authors.forename: Fabiola C
authors.initials: FC
authors.lastname: Bento
mesh_terms: D000328:Adult; D016902:Air Pollution, Indoor; D001938:Brazil; D004780:Environment, Controlled; D004784:Environmental Monitoring; D005062:European Union; D005260:Female; D006801:Humans; D008297:Male; D011247:Pregnancy; D011256:Pregnancy Outcome; D018456:Reproductive Medicine / Q000331:legislation & jurisprudence; D012189:Retrospective Studies; D013048:Specimen Handling / Q000592:standards*; D020554:Sperm Injections, Intracytoplasmic; D014691:Ventilation