Edgar Mocanu ¹,*, Andrew Drakeley² , Markus S. Kupka³ , Evelin E. Lara-Molina⁴ , Nathalie Le Clef ⁵ , Willem Ombelet⁶ , Catherine Patrat 7 , Guido Pennings 8 , Augusto Enrico Semprini⁹ , Kelly Tilleman¹⁰, Mauro Tognon ¹¹, Nino Tonch^12, and Bryan Woodward¹³

• ¹ Department of Reproductive Medicine, Rotunda Hospital, Royal College of Surgeons in Ireland, Dublin, Ireland
• ² Department of Reproductive Medicine, Liverpool Women’s Hospital, Liverpool, UK
• ³ Department Gynaecology and Obstetrics, Gynaekologicum Hamburg, Hamburg, Germany
• ⁴ Department of Egg Donation, IVI RMA Global Barcelona, Barcelona, Spain
• ⁵ European Society of Human Reproduction and Embryology, Grimbergen, Belgium
• ⁶ Genk Institute for Fertility Technology, ZOL Hospitals, Genk Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium
• ⁷ APHP Centre—University of Paris, Cochin, Service de Biologie de la Reproduction—CECOS, Paris, France
• ⁸ Department of Philosophy and Moral Science, Bioethics Institute Ghent (BIG) Ghent University, Gent, Belgium 9 Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy
• ¹⁰Department for Reproductive Medicine, Ghent University Hospital, Gent, Belgium
• ¹¹Department of Medical Sciences, University of Ferrara School of Medicine, Ferrara, Italy
• ¹²Department of Reproductive Medicine, Amsterdam University Medical Centre, Location AMC, Amsterdam, The Netherlands 13X&Y Fertility, Leicester, UK

STUDY QUESTION: What is the recommended management for medically assisted reproduction (MAR) in patients with a viral infection or disease, based on the best available evidence in the literature?

SUMMARY ANSWER: The ESHRE guideline on MAR in patients with a viral infection/disease makes 78 recommendations on prevention of horizontal and vertical transmission before, during and after MAR, and the impact on its outcomes, and these also include recommendations regarding laboratory safety on the processing and storage of gametes and embryos testing positive for viral infections.

WHAT IS KNOWN ALREADY: The development of new and improved anti-viral medications has resulted in improved life expectancy and quality of life for patients with viral infections/diseases. Patients of reproductive age are increasingly exploring their options for family creation.

STUDY DESIGN, SIZE, DURATION: The guideline was developed according to the structured methodology for the development of ESHRE guidelines. After the formulation of nine key questions for six viruses (hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human papilloma virus, human T-lymphotropic virus I/II and Zika virus) by a group of experts, literature searches and assessments were performed. Papers published up to 2 November 2020 and written in English were included in the review. Evidence was analyzed by female, male or couple testing positive for the virus

PARTICIPANTS/MATERIALS, SETTING, METHODS: Based on the collected evidence, recommendations were formulated and discussed until consensus was reached within the guideline group. There were 61 key questions to be answered by the guideline development group (GDG), of which 12 were answered as narrative questions and 49 as PICO (Patient, Intervention, Comparison, Outcome) questions. A stakeholder review was organized after the finalization of the draft. The final version was approved by the GDG and the ESHRE Executive Committee.

MAIN RESULTS AND THE ROLE OF CHANCE: This guideline aims to help providers meet a growing demand for guidance on the management of patients with a viral infection/disease presenting in the fertility clinic.

The guideline makes 78 recommendations on prevention of viral transmission before and during MAR, and interventions to reduce/avoid vertical transmission to the newborn. Preferred MAR treatments and interventions are described together with the effect of viral infections on outcomes. The GDG formulated 44 evidence-based recommendations—of which 37 were formulated as strong recommendations and 7 as weak—33 good practice points (GPP) and one research only recommendation. Of the evidence-based recommendations, none were supported by high-quality evidence, two by moderate-quality evidence, 15 by low-quality evidence and 27 by very low-quality evidence. To support future research in the field of MAR in patients with a viral infection/disease, a list of research recommendations is provided.

LIMITATIONS, REASONS FOR CAUTION: Most interventions included are not well-studied in patients with a viral infection/disease. For a large proportion of interventions, evidence was very limited and of very low quality. More evidence is required for these interventions, especially in the field of human papilloma virus (HPV). Such future studies may require the current recommendations to be revised.

WIDER IMPLICATIONS OF THE FINDINGS: The guideline provides clinicians with clear advice on best practice in MAR for patients with a viral infection/disease, based on the best evidence currently available. In addition, a list of research recommendations is provided to stimulate further studies in the field.

STUDY FUNDING/COMPETING INTEREST(S): The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, with the literature searches and with the dissemination of the guideline. The guideline group members did not receive any financial incentives, all work was provided voluntarily. A.D. reports research fees from Ferring and Merck, consulting fees from Ferring, outside the submitted work. C.P. reports speakers fees from Merck and MSD outside the submitted work. K.T. reports speakers fees from Cooper Surgical and Ferring and consultancy fees as member of the advisory board BioTeam of Ferring, outside the submitted work. The other authors have no conflicts of interest to declare.

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