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      The International Glossary on Infertility and Fertility Care, 2017 ‡§

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          Abstract

          STUDY QUESTION

          Can a consensus and evidence-driven set of terms and definitions be generated to be used globally in order to ensure consistency when reporting on infertility issues and fertility care interventions, as well as to harmonize communication among the medical and scientific communities, policy-makers, and lay public including individuals and couples experiencing fertility problems?

          SUMMARY ANSWER

          A set of 283 consensus-based and evidence-driven terminologies used in infertility and fertility care has been generated through an inclusive consensus-based process with multiple stakeholders.

          WHAT IS KNOWN ALREADY

          In 2006 the International Committee for Monitoring Assisted Reproductive Technologies (ICMART) published a first glossary of 53 terms and definitions. In 2009 ICMART together with WHO published a revised version expanded to 87 terms, which defined infertility as a disease of the reproductive system, and increased standardization of fertility treatment terminology. Since 2009, limitations were identified in several areas and enhancements were suggested for the glossary, especially concerning male factor, demography, epidemiology and public health issues.

          STUDY DESIGN, SIZE, DURATION

          Twenty-five professionals, from all parts of the world and representing their expertise in a variety of sub-specialties, were organized into five working groups: clinical definitions; outcome measurements; embryology laboratory; clinical and laboratory andrology; and epidemiology and public health. Assessment for revisions, as well as expansion on topics not covered by the previous glossary, were undertaken. A larger group of independent experts and representatives from collaborating organizations further discussed and assisted in refining all terms and definitions.

          PARTICIPANTS/MATERIALS, SETTING, METHODS

          Members of the working groups and glossary co-ordinators interacted through electronic mail and face-to-face in international/regional conferences. Two formal meetings were held in Geneva, Switzerland, with a final consensus meeting including independent experts as well as observers and representatives of international/regional scientific and patient organizations.

          MAIN RESULTS AND THE ROLE OF CHANCE

          A consensus-based and evidence-driven set of 283 terminologies used in infertility and fertility care was generated to harmonize communication among health professionals and scientists as well as the lay public, patients and policy makers. Definitions such as ‘fertility care’ and ‘fertility awareness’ together with terminologies used in embryology and andrology have been introduced in the glossary for the first time. Furthermore, the definition of ‘infertility’ has been expanded in order to cover a wider spectrum of conditions affecting the capacity of individuals and couples to reproduce. The definition of infertility remains as a disease characterized by the failure to establish a clinical pregnancy; however, it also acknowledges that the failure to become pregnant does not always result from a disease, and therefore introduces the concept of an impairment of function which can lead to a disability. Additionally, subfertility is now redundant, being replaced by the term infertility so as to standardize the definition and avoid confusion.

          LIMITATIONS, REASONS FOR CAUTION

          All stakeholders agreed to the vast majority of terminologies included in this glossary. In cases where disagreements were not resolved, the final decision was reached after a vote, defined before the meeting as consensus if passed with 75%. Over the following months, an external expert group, which included representatives from non-governmental organizations, reviewed and provided final feedback on the glossary.

          WIDER IMPLICATIONS OF THE FINDINGS

          Some terminologies have different definitions, depending on the area of medicine, for example demographic or clinical as well as geographic differences. These differences were taken into account and this glossary represents a multinational effort to harmonize terminologies that should be used worldwide.

          STUDY FUNDING/COMPETING INTERESTS

          None.

          TRIAL REGISTRATION NUMBER

          N/A.

          Related collections

          Most cited references6

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          Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement

          Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples.
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            Is Open Access

            Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement.

            (2014)
            Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which creates a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant after ≥20 weeks' gestation) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples.
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              The ICMART glossary on ART terminology.

              The International Committee Monitoring Assisted Reproductive Technologies (ICMART) is an independent, international non-profit organization that has taken a leading role in the development, collection and dissemination of worldwide data on ART. Information on availability, efficacy and safety is provided to health professionals, health authorities and the public. The glossary facilitates dissemination of ART data through a set of agreed definitions as seen in the most recent World Report on ART. It provides a conceptual framework for further international terminology and data development of ART.
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                Author and article information

                Journal
                Hum Reprod
                Hum. Reprod
                humrep
                Human Reproduction (Oxford, England)
                Oxford University Press
                0268-1161
                1460-2350
                September 2017
                28 July 2017
                28 July 2017
                : 32
                : 9
                : 1786-1801
                Affiliations
                [1 ] University Diego Portales , Program of Ethics and Public Policies in Human Reproduction; Clinica las Condes, Unit of Reproductive Medicine, Santiago, Chile
                [2 ] ICMART, Palo Alto Medical Foundation Fertility Physicians of Northern California, Palo Alto, CA, USA
                [3 ] Department of Obstetrics & Gynecology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town , Cape Town, South Africa
                [4 ] Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA
                [5 ] INSERM, EIM-ESHRE, ICMART, 15 rue Guilleminot, 75014 Paris, France
                [6 ] Department of Medicine and Obstetrics and Gynecology, Keck School of Medicine, University of Southern California , Los Angeles, CA 90007, USA
                [7 ] GENERA Center for Reproductive Medicine, Valle Giulia Clinic, 00197 Rome, Italy
                [8 ] Department of Obstetrics and Gynecology, St. Olav's University Hospital , Trondheim, Norway
                [9 ] Institute of Public Health, University of Copenhagen , Copenhagen, Denmark
                [10 ] Academic Unit of Reproductive and Developmental Medicine, Department of Oncology and Metabolism, University of Sheffield , Sheffield, UK
                [11 ] March of Dimes Foundation, White Plains, NY, USA
                [12 ] The Population Council, The Rockefeller University, New York, NY 10065, USA
                Author notes
                [* ]Correspondence address. ICMART c/o International Conference Services (ICS), Suite 300, 1201 West Pender Street, Vancouver, BC, Canada V6E2V2. Tel: +1 (604) 681-2153; E-mail: icmart@ 123456icsevents.com
                [‡]

                ESHRE Pages are not externally peer reviewed. The manuscript has been approved by the Executive Committee of ESHRE.

                [§]

                This article is simultaneously published in Fertility and Sterility.

                Article
                dex234
                10.1093/humrep/dex234
                5850297
                29117321
                928f2bca-5fb0-455f-8194-8333110b6b38
                © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the properly cited. For work is commercial re-use, please contact journals.permissions@ 123456oup.com .

                History
                : 18 May 2017
                : 05 June 2017
                Page count
                Pages: 16
                Categories
                ESHRE Pages

                Human biology
                glossary,terminologies,infertility,fertility care,art
                Human biology
                glossary, terminologies, infertility, fertility care, art

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