ResearchPad - eshre-pages https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[ESHRE guideline: ovarian stimulation for IVF/ICSI<sup>†</sup>]]> https://www.researchpad.co/article/N08974592-7b68-4e59-a06e-80e06181b44a What is the recommended management of ovarian stimulation, based on the best available evidence in the literature?SUMMARY ANSWERThe guideline development group formulated 84 recommendations answering 18 key questions on ovarian stimulation.WHAT IS KNOWN ALREADYOvarian stimulation for IVF/ICSI has been discussed briefly in the National Institute for Health and Care Excellence guideline on fertility problems, and the Royal Australian and New Zealand College of Obstetricians and Gynaecologist has published a statement on ovarian stimulation in assisted reproduction. There are, to our knowledge, no evidence-based guidelines dedicated to the process of ovarian stimulation.STUDY DESIGN, SIZE, DURATIONThe guideline was developed according to the structured methodology for development of ESHRE guidelines. After formulation of key questions by a group of experts, literature searches and assessments were performed. Papers published up to 8 November 2018 and written in English were included. The critical outcomes for this guideline were efficacy in terms of cumulative live birth rate per started cycle or live birth rate per started cycle, as well as safety in terms of the rate of occurrence of moderate and/or severe ovarian hyperstimulation syndrome (OHSS).PARTICIPANTS/MATERIALS, SETTING, METHODSBased on the collected evidence, recommendations were formulated and discussed until consensus was reached within the guideline group. A stakeholder review was organized after finalization of the draft. The final version was approved by the guideline group and the ESHRE Executive Committee.MAIN RESULTS AND THE ROLE OF CHANCEThe guideline provides 84 recommendations: 7 recommendations on pre-stimulation management, 40 recommendations on LH suppression and gonadotrophin stimulation, 11 recommendations on monitoring during ovarian stimulation, 18 recommendations on triggering of final oocyte maturation and luteal support and 8 recommendations on the prevention of OHSS. These include 61 evidence-based recommendations—of which only 21 were formulated as strong recommendations—and 19 good practice points and 4 research-only recommendations. The guideline includes a strong recommendation for the use of either antral follicle count or anti-Müllerian hormone (instead of other ovarian reserve tests) to predict high and poor response to ovarian stimulation. The guideline also includes a strong recommendation for the use of the GnRH antagonist protocol over the GnRH agonist protocols in the general IVF/ICSI population, based on the comparable efficacy and higher safety. For predicted poor responders, GnRH antagonists and GnRH agonists are equally recommended. With regards to hormone pre-treatment and other adjuvant treatments (metformin, growth hormone (GH), testosterone, dehydroepiandrosterone, aspirin and sildenafil), the guideline group concluded that none are recommended for increasing efficacy or safety.LIMITATIONS, REASON FOR CAUTIONSeveral newer interventions are not well studied yet. For most of these interventions, a recommendation against the intervention or a research-only recommendation was formulated based on insufficient evidence. Future studies may require these recommendations to be revised.WIDER IMPLICATIONS OF THE FINDINGSThe guideline provides clinicians with clear advice on best practice in ovarian stimulation, based on the best evidence available. In addition, a list of research recommendations is provided to promote further studies in ovarian stimulation.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 payment. F.B. reports research grant from Ferring and consulting fees from Merck, Ferring, Gedeon Richter and speaker’s fees from Merck. N.P. reports research grants from Ferring, MSD, Roche Diagnositics, Theramex and Besins Healthcare; consulting fees from MSD, Ferring and IBSA; and speaker’s fees from Ferring, MSD, Merck Serono, IBSA, Theramex, Besins Healthcare, Gedeon Richter and Roche Diagnostics. A.L.M reports research grants from Ferring, MSD, IBSA, Merck Serono, Gedeon Richter and TEVA and consulting fees from Roche, Beckman-Coulter. G.G. reports consulting fees from MSD, Ferring, Merck Serono, IBSA, Finox, Theramex, Gedeon-Richter, Glycotope, Abbott, Vitrolife, Biosilu, ReprodWissen, Obseva and PregLem and speaker’s fees from MSD, Ferring, Merck Serono, IBSA, Finox, TEVA, Gedeon Richter, Glycotope, Abbott, Vitrolife and Biosilu. E.B. reports research grants from Gedeon Richter; consulting and speaker’s fees from MSD, Ferring, Abbot, Gedeon Richter, Merck Serono, Roche Diagnostics and IBSA; and ownership interest from IVI-RMS Valencia. P.H. reports research grants from Gedeon Richter, Merck, IBSA and Ferring and speaker’s fees from MSD, IBSA, Merck and Gedeon Richter. J.U. reports speaker’s fees from IBSA and Ferring. N.M. reports research grants from MSD, Merck and IBSA; consulting fees from MSD, Merck, IBSA and Ferring and speaker’s fees from MSD, Merck, IBSA, Gedeon Richter and Theramex. M.G. reports speaker’s fees from Merck Serono, Ferring, Gedeon Richter and MSD. S.K.S. reports speaker’s fees from Merck, MSD, Ferring and Pharmasure. E.K. reports speaker’s fees from Merck Serono, Angellini Pharma and MSD. M.K. reports speaker’s fees from Ferring. T.T. reports speaker’s fees from Merck, MSD and MLD. The other authors report no conflicts of interest.Disclaimer This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained. Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgment to each individual presentation, nor variations based on locality and facility type. ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. (Full disclaimer available at www.eshre.eu/guidelines.) ESHRE Pages content is not externally peer reviewed. The manuscript has been approved by the Executive Committee of ESHRE. ]]> <![CDATA[Survey on ART and IUI: legislation, regulation, funding and registries in European countries]]> https://www.researchpad.co/article/N4f115426-6ad9-44ad-9a34-cbe8b29df8be

Abstract

STUDY QUESTION

How are ART and IUI regulated, funded and registered in European countries?

SUMMARY ANSWER

Of the 43 countries performing ART and IUI in Europe, and participating in the survey, specific legislation exists in only 39 countries, public funding (also available in the 39 countries) varies across and sometimes within countries and national registries are in place in 31 countries.

WHAT IS KNOWN ALREADY

Some information devoted to particular aspects of accessibility to ART and IUI is available, but most is fragmentary or out-dated. Annual reports from the European IVF-Monitoring (EIM) Consortium for ESHRE clearly mirror different approaches in European countries regarding accessibility to and efficacy of those techniques.

STUDY DESIGN, SIZE, DURATION

A survey was designed using the online SurveyMonkey tool consisting of 55 questions concerning three domains—legal, funding and registry. Answers refer to the countries’ situation on 31 December 2018.

PARTICIPANTS/MATERIALS, SETTINGS, METHODS

All members of EIM plus representatives of countries not yet members of the Consortium were invited to participate. Answers received were checked, and initial responders were asked to address unclear answers and to provide any additional information they considered important. Tables of individual countries resulting from the consolidated data were then sent to members of the Committee of National Representatives of ESHRE, asking for a second check. Conflicting information was clarified by direct contact.

MAIN RESULTS AND THE ROLE OF CHANCE

Information was received from 43 out of the 44 European countries where ART and IUI are performed. Thirty-nine countries reported specific legislation on ART, and artificial insemination was considered an ART technique in 35 of them. Accessibility is limited to infertile couples in 11 of the 43 countries. A total of 30 countries offer treatments to single women and 18 to female couples. In five countries ART and IUI are permitted for treatment of all patient groups, being infertile couples, single women and same sex couples, male and female. Use of donated sperm is allowed in 41 countries, egg donation in 38, the simultaneous donation of sperm and egg in 32 and embryo donation in 29. Preimplantation genetic testing (PGT) for monogenic disorders or structural rearrangements is not allowed in two countries, and PGT for aneuploidy is not allowed in 11; surrogacy is accepted in 16 countries. With the exception of marital/sexual situation, female age is the most frequently reported limiting criteria for legal access to ART—minimal age is usually set at

18 years and maximum ranging from 45 to 51 years with some countries not using numeric definition. Male maximum age is set in very few countries. Where permitted, age is frequently a limiting criterion for third-party donors (male maximum age 35 to 55 years; female maximum age 34 to 38 years). Other legal constraints in third-party donation are the number of children born from the same donor (in some countries, number of families with children from the same donor) and, in 10 countries, a maximum number of egg donations. How countries deal with the anonymity is diverse—strict anonymity, anonymity just for the recipients (not for children when reaching legal adulthood age), mixed system (anonymous and non-anonymous donations) and strict non-anonymity.

Public funding systems are extremely variable. Four countries provide no financial assistance to patients. Limits to the provision of funding are defined in all the others i.e. age (female maximum age is the most used), existence of previous children, maximum number of treatments publicly supported and techniques not entitled for funding. In a few countries, reimbursement is linked to a clinical policy. The definition of the type of expenses covered within an IVF/ICSI cycle, up to what limit and the proportion of out-of-pocket costs for patients is also extremely dissimilar.

National registries of ART and IUI are in place in 31 out of the 43 countries contributing to the survey, and a registry of donors exists in 18 of them.

LIMITATIONS, REASONS FOR CAUTION

The responses were provided by well-informed and committed individuals and submitted to double checking. Since no formal validation was in place, possible inaccuracies cannot be excluded. Also, results are a cross section in time and ART and IUI legislations within European countries undergo continuous evolution. Finally, several domains of ART activity were deliberately left out of the scope of this ESHRE survey.

WIDER IMPLICATIONS OF THE FINDINGS

Results of this survey offer a detailed view of the ART and IUI situation in European countries. It provides updated and extensive answers to many relevant questions related to ART usage at national level and could be used by institutions and policymakers in planning services at both national and European levels.

Study funding/competing interest(s)

The study has no external funding, and all costs were covered by ESHRE. There were no competing interests.

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

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<![CDATA[Recommendations for good practice in ultrasound: oocyte pick up†]]> https://www.researchpad.co/article/Nea624f33-03fd-4155-afd3-c84a4d18a6ed

Abstract

STUDY QUESTION

What is good practice in ultrasound (US), and more specifically during the different stages of transvaginal oocyte retrieval, based on evidence in the literature and expert opinion on US practice in ART?

SUMMARY ANSWER

This document provides good practice recommendations covering technical aspects of US-guided transvaginal oocyte retrieval (oocyte pick up: OPU) formulated by a group of experts after considering the published data, and including the preparatory stage of OPU, the actual procedure and post-procedure care.

WHAT IS KNOWN ALREADY

US-guided transvaginal OPU is a widely performed procedure, but standards for best practice are not available.

STUDY DESIGN, SIZE, DURATION

A working group (WG) collaborated on writing recommendations on the practical aspects of transvaginal OPU. A literature search for evidence of the key aspects of the procedure was carried out. Selected papers (n = 190) relevant to the topic were analyzed by the WG.

PARTICIPANTS/MATERIALS, SETTING, METHODS

The WG members considered the following key points in the papers: whether US practice standards were explained; to what extent the OPU technique was described and whether complications or incidents and how to prevent such events were reported. In the end, only 108 papers could be used to support the recommendations in this document, which focused on transvaginal OPU. Laparoscopic OPU, transabdominal OPU and OPU for IVM were outside the scope of the study.

MAIN RESULTS AND THE ROLE OF CHANCE

There was a scarcity of studies on the actual procedural OPU technique. The document presents general recommendations for transvaginal OPU, and specific recommendations for its different stages, including prior to, during and after the procedure. Most evidence focussed on comparing different equipment (needles) and on complications and risks, including the risk of infection. For these topics, the recommendations were largely based on the results of the studies. Recommendations are provided on equipment and materials, possible risks and complications, audit and training. One of the major research gaps was training and competence. This paper has also outlined a list of research priorities (including clarification on the value or full blood count, antibiotic prophylaxis and flushing, and the need for training and proficiency).

LIMITATIONS, REASONS FOR CAUTION

The recommendations of this paper were mostly based on clinical expertise, as at present, only a few clinical trials have focused on the oocyte retrieval techniques, and almost all available data are observational. In addition, studies focusing on OPU were heterogeneous with significant difference in techniques used, which made drafting conclusions and recommendations based on these studies even more challenging.

WIDER IMPLICATIONS OF THE FINDINGS

These recommendations complement previous guidelines on the management of good laboratory practice in ART. Some useful troubleshooting/checklist recommendations are given for easy implementation in clinical practice. These recommendations aim to contribute to the standardization of a rather common procedure that is still performed with great heterogeneity.

STUDY FUNDING/COMPETING INTEREST(S)

The meetings of the WG were funded by ESHRE. The other authors declare that they have no conflict of interest.

TRIAL REGISTRATION NUMBER

NA.

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

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<![CDATA[Responsible innovation in human germline gene editing. Background document to the recommendations of ESHG and ESHRE†‡]]> https://www.researchpad.co/article/5c9e53a9d5eed0c484239622

Abstract

Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique could help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? This Background document summarizes the scientific developments and expectations regarding germline gene editing, legal regulations at the European level, and ethics for three different settings (basic research, pre-clinical research and clinical applications). In ethical terms, we argue that the deontological objections (e.g. gene editing goes against nature) do not seem convincing while consequentialist objections (e.g. safety for the children thus conceived and following generations) require research, not all of which is allowed in the current legal situation in European countries. Development of this Background document and Recommendations reflects the responsibility to help society understand and debate the full range of possible implications of the new technologies, and to contribute to regulations that are adapted to the dynamics of the field while taking account of ethical considerations and societal concerns.

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<![CDATA[Human germline gene editing. Recommendations of ESHG and ESHRE†‡]]> https://www.researchpad.co/article/5c9e53aed5eed0c48423969a

Abstract

Technological developments in gene editing raise high expectations for clinical applications, first of all for somatic gene editing but in theory also for germline gene editing (GLGE). GLGE is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if GLGE would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique can help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. After consulting its membership and experts, this final version of the Recommendations was endorsed by the Executive Committee and the Board of the respective Societies in May 2017. Taking account of ethical arguments, we argue that both basic and pre-clinical research regarding human GLGE can be justified, with conditions. Furthermore, while clinical GLGE would be totally premature, it might become a responsible intervention in the future, but only after adequate pre-clinical research. Safety of the child and future generations is a major concern. Future discussions must also address priorities among reproductive and potential non-reproductive alternatives, such as PGD and somatic editing, if that would be safe and successful. The prohibition of human germline modification, however, needs renewed discussion among relevant stakeholders, including the general public and legislators.

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<![CDATA[The Vienna consensus: report of an expert meeting on the development of art laboratory performance indicators†‡]]> https://www.researchpad.co/article/5c9e539cd5eed0c4842394bb

Abstract

STUDY QUESTION

What are appropriate performance indicators (PIs) for ART laboratories for use in monitoring ‘fresh’ IVF and ICSI cycles?

SUMMARY ANSWER

Minimum performance (competence) levels and aspirational (benchmark) values were recommended for a total of 19 indicators, including 12 key PIs (KPIs), five PIs and two reference indicators (RIs).

WHAT IS ALREADY KNOWN

PIs are necessary for systematic monitoring of the laboratory and an important element within the Quality Management System. However, there are no established PIs for ART laboratories and there is very little evidence on the topic.

STUDY DESIGN, SIZE, DURATION

This is the report of a 2-day consensus meeting of expert professionals. As a starting point for the discussion, two surveys were organized to collect information on indicators used in IVF laboratories. During the meeting, the results of the surveys, scientific evidence (where available), and personal clinical experience where integrated into presentations by experts on specific topics. After presentation, each proposed indicator was discussed until consensus was reached within the panel.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Expert professionals representing different countries and settings convened in the consensus meeting.

MAIN RESULTS AND THE ROLE OF CHANCE

The paper is divided in two parts: the workshop report and the recommendations of the expert panel. The second part reflects the discussion on each of the indicators, with the agreed definition, competence level and benchmark value for each of the 19 indicators, including 12 KPIs, 5 PIs and 2 RIs.

LIMITATIONS, REASONS FOR CAUTION

The KPIs are mainly based on expert opinion. Future research may warrant an update of the recommended KPIs, their definition and the competence level and benchmark values.

WIDER IMPLICATIONS OF THE FINDINGS

Based on the information presented, each ART laboratory should select its own set of KPIs founded on laboratory organization, and processes.

STUDY FUNDING/COMPETING INTEREST(S)

The consensus meeting and writing of the paper was supported by funds from ESHRE and Alpha. Alpha gratefully acknowledges the following organizations for their financial support, through the provision of unrestricted educational grants: Global Fertility Alliance, Merck, Origio and Vitrolife. There are no conflicts of interest to disclose,

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<![CDATA[Two decades of embryonic stem cells: a historical overview]]> https://www.researchpad.co/article/5c9e5601d5eed0c48423d403

Abstract

STUDY QUESTION

How did the field of stem cell research develop in the years following the derivation of the first human embryonic stem cell (hESC) line?

SUMMARY ANSWER

Supported by the increasing number of clinical trials to date, significant technological advances in the past two decades have brought us ever closer to clinical therapies derived from pluripotent cells.

WHAT IS KNOWN ALREADY

Since their discovery 20 years ago, the use of human pluripotent stem cells has progressed tremendously from bench to bedside. Here, we provide a concise review of the main keystones of this journey and focus on ongoing clinical trials, while indicating the most relevant future research directions.

STUDY DESIGN, SIZE, DURATION

This is a historical narrative, including relevant publications in the field of pluripotent stem cells (PSC) derivation and differentiation, recounted both through scholarly research of published evidence and interviews of six pioneers who participated in some of the most relevant discoveries in the field.

PARTICIPANTS/MATERIALS, SETTING, METHODS

The authors all contributed by researching the literature and agreed upon body of works. Portions of the interviews of the field pioneers have been integrated into the review and have also been included in full for advanced reader interest.

MAIN RESULTS AND THE ROLE OF CHANCE

The stem cell field is ever expanding. We find that in the 20 years since the derivation of the first hESC lines, several relevant developments have shaped the pluripotent cell field, from the discovery of different states of pluripotency, the derivation of induced PSC, the refinement of differentiation protocols with several clinical trials underway, as well as the recent development of organoids. The challenge for the years to come will be to validate and refine PSCs for clinical use, from the production of highly defined cell populations in clinical grade conditions to the possibility of creating replacement organoids for functional, if not anatomical, function restoration.

LIMITATIONS, REASONS FOR CAUTION

This is a non-systematic review of current literature. Some references may have escaped the experts’ analysis due to the exceedingly diverse nature of the field. As the field of regenerative medicine is rapidly advancing, some of the most recent developments may have not been captured entirely.

WIDER IMPLICATIONS OF THE FINDINGS

The multi-disciplinary nature and tremendous potential of the stem cell field has important implications for basic as well as translational research. Recounting these activities will serve to provide an in-depth overview of the field, fostering a further understanding of human stem cell and developmental biology. The comprehensive overview of clinical trials and expert opinions included in this narrative may serve as a valuable scientific resource, supporting future efforts in translational approaches.

STUDY FUNDING/COMPETING INTEREST(S)

ESHRE provided funding for the authors’ on-site meeting and discussion during the preparation of this manuscript. S.M.C.S.L. is funded by the European Research Council Consolidator (ERC-CoG-725722-OVOGROWTH). M.P. is supported by the Special Research Fund, Bijzonder Onderzoeksfonds (BOF01D08114). M.G. is supported by the Methusalem grant of Vrije Universiteit Brussel, in the name of Prof. Karen Sermon and by Innovation by Science and Technology in Flanders (IWT, Project Number: 150042). A.V. and B.A. are supported by the Plataforma de Proteomica, Genotipado y Líneas Celulares (PT1770019/0015) (PRB3), Instituto de Salud Carlos III. Research grant to B.H. by the Research Foundation—Flanders (FWO) (FWO.KAN.2016.0005.01 and FWO.Project G051516N). There are no conflicts of interest to declare.

TRIAL REGISTRATION NUMBER

Not applicable.

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

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<![CDATA[ESHRE guideline: recurrent pregnancy loss]]> https://www.researchpad.co/article/5c9e53a1d5eed0c484239536

Abstract

STUDY QUESTION

What is the recommended management of women with recurrent pregnancy loss (RPL) based on the best available evidence in the literature?

SUMMARY ANSWER

The guideline development group formulated 77 recommendations answering 18 key questions on investigations and treatments for RPL, and on how care should be organized.

WHAT IS KNOWN ALREADY

A previous guideline for the investigation and medical treatment of recurrent miscarriage was published in 2006 and is in need of an update.

STUDY DESIGN, SIZE, DURATION

The guideline was developed according to the structured methodology for development of ESHRE guidelines. After formulation of key questions by a group of experts, literature searches and assessments were performed. Papers published up to 31 March 2017 and written in English were included. Cumulative live birth rate, live birth rate and pregnancy loss rate (or miscarriage rate) were considered the critical outcomes.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Based on the collected evidence, recommendations were formulated and discussed until consensus was reached within the guideline group. A stakeholder review was organized after finalization of the draft. The final version was approved by the guideline group and the ESHRE Executive Committee.

MAIN RESULTS AND THE ROLE OF CHANCE

The guideline provides 38 recommendations on risk factors, prevention and investigations in couples with RPL, and 39 recommendations on treatments. These include 60 evidence-based recommendations – of which 31 were formulated as strong recommendations and 29 as conditional – and 17 good practice points. The evidence supporting investigations and treatment of couples with RPL is limited and of moderate quality. Of the evidence-based recommendations, only 10 (16.3%) were supported by moderate quality evidence. The remaining recommendations were supported by low (35 recommendations: 57.4%), or very low quality evidence (16 recommendations: 26.2%). There were no recommendations based on high quality evidence. Owing to the lack of evidence-based investigations and treatments in RPL care, the guideline also clearly mentions investigations and treatments that should not be used for couples with RPL.

LIMITATIONS, REASONS FOR CAUTION

Several investigations and treatments are offered to couples with RPL, but most of them are not well studied. For most of these investigations and treatments, a recommendation against the intervention or treatment was formulated based on insufficient evidence. Future studies may require these recommendations to be revised.

WIDER IMPLICATIONS OF THE FINDINGS

The guideline provides clinicians with clear advice on best practice in RPL, based on the best evidence available. In addition, a list of research recommendations is provided to stimulate further studies in RPL. One of the most important consequences of the limited evidence is the absence of evidence for a definition of RPL.

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 payment. J.E. reports position funding from CARE Fertility. S.L. reports position funding from SpermComet Ltd. S.M. reports research grants, consulting and speaker’s fees from GSK, BMS/Pfizer, Sanquin, Aspen, Bayer and Daiichi Sankyo. S.Q. reports speaker’s fees from Ferring. The other authors report no conflicts of interest.

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

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<![CDATA[Evidence summaries and recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome: assessment and treatment of infertility]]> https://www.researchpad.co/article/5c9e55f9d5eed0c48423d359

Abstract

STUDY QUESTION

What is the recommended assessment and management of infertile women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertize and consumer preference?

SUMMARY ANSWER

International evidence-based guidelines, including 44 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of infertile women with PCOS.

WHAT IS KNOWN ALREADY

Previous guidelines on PCOS lacked rigorous evidence-based processes, failed to engage consumer and multidisciplinary perspectives or were outdated. The assessment and management of infertile women with PCOS are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Governance included a six continent international advisory and a project board, a multidisciplinary international guideline development group (GDG), consumer and translation committees. Extensive health professional and consumer engagement informed the guideline scope and priorities. The engaged international society-nominated panel included endocrinology, gynaecology, reproductive endocrinology, obstetrics, public health and other experts, alongside consumers, project management, evidence synthesis and translation experts. Thirty-seven societies and organizations covering 71 countries engaged in the process. Extensive online communication and two face-to-face meetings over 15 months addressed 19 prioritized clinical questions involving nine evidence-based reviews and 10 narrative reviews. Evidence-based recommendations (EBRs) were formulated prior to consensus voting within the guideline panel.

STUDY DESIGN, SIZE, DURATION

International evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. A (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, desirable and undesirable consequences, feasibility, acceptability, cost, implementation and ultimately recommendation strength. The guideline was peer-reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREE II criteria and underwent methodological review. This guideline was approved by all members of the GDG and has been approved by the NHMRC.

MAIN RESULTS AND THE ROLE OF CHANCE

The quality of evidence (QOE) for the EBRs in the assessment and management of infertility in PCOS included very low (n = 1), low (n = 9) and moderate (n = 4) quality with no EBRs based on high-quality evidence. The guideline provides 14 EBRs, 10 clinical consensus recommendations (CCRs) and 20 clinical practice points on the assessment and management of infertility in PCOS. Key changes in this guideline include emphasizing evidence-based fertility therapy, including cheaper and safer fertility management.

LIMITATIONS, REASONS FOR CAUTION

Overall evidence is generally of low to moderate quality, requiring significantly greater research in this neglected, yet common condition. Regional health systems vary and a process for adaptation of this guideline is provided.

WIDER IMPLICATIONS OF THE FINDINGS

The international guideline for the assessment and management of infertility in PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program.

STUDY FUNDING/COMPETING INTEREST(S)

The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine (ASRM). GDG members did not receive payment. Travel expenses were covered by the sponsoring organizations. Disclosures of conflicts of interest were declared at the outset and updated throughout the guideline process, aligned with NHMRC guideline processes. Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Norman has declared a minor shareholder interest in the IVF unit Fertility SA, travel support from Merck and grants from Ferring. Prof. Norman also has scientific advisory board duties for Ferring. The remaining authors have no conflicts of interest to declare.

This article was not externally peer-reviewed by Human Reproduction Open.

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<![CDATA[Oocyte and ovarian tissue cryopreservation in European countries: statutory background, practice, storage and use†]]> https://www.researchpad.co/article/5c9e539fd5eed0c484239513

Abstract

STUDY QUESTION

What is known in Europe about the practice of oocyte cryopreservation (OoC), in terms of current statutory background, funding conditions, indications (medical and ‘non-medical’) and specific number of cycles?

SUMMARY ANSWER

Laws and conditions for OoC vary in Europe, with just over half the responding countries providing this for medical reasons with state funding, and none providing funding for ‘non-medical’ OoC.

WHAT IS ALREADY KNOWN

The practice of OoC is a well-established and increasing practice in some European countries, but data gathering on storage is not homogeneous, and still sparse for use. Ovarian tissue cryopreservation (OtC) is only practiced and registered in a few countries.

STUDY DESIGN, SIZE, AND DURATION

A transversal collaborative survey on OoC and OtC, was designed, based on a country questionnaire containing information on statutory or professional background and practice, as well as available data on ovarian cell and tissue collection, storage and use. It was performed between January and September 2015.

PARTICIPANTS/MATERIALS, SETTING AND METHODS

All ESHRE European IVF Monitoring (EIM) consortium national coordinators were contacted, as well as members of the ESHRE committee of national representatives, and sent a questionnaire. The form included national policy and practice details, whether through current existing law or code of practice, criteria for freezing (age, health status), availability of funding and the presence of a specific register. The questionnaire also included data on both the number of OoC cycles and cryopreserved oocytes per year between 2010 and 2014, specifically for egg donation, fertility preservation for medical disease, ‘other medical’ reasons as part of an ART cycle, as well as for ‘non-medical reasons’ or age-related fertility decline. Another question concerning data on freezing and use of ovarian tissue over 5 years was added and sent after receiving the initial questionnaire.

MAIN RESULTS AND THE ROLE OF CHANCE

Out of 34 EIM members, we received answers regarding OoC regulations and funding conditions from 27, whilst 17 countries had recorded data for OoC, and 12 for OtC. The specific statutory framework for OoC and OtC varies from absent to a strict frame. A total of 34 705 OoC cycles were reported during the 5-year-period, with a continuous increase. However, the accurate description of numbers was concentrated on the year 2013 because it was the most complete. In 2013, a total of 9126 aspirations involving OoC were reported from 16 countries. Among the 8885 oocyte aspirations with fully available data, the majority or 5323 cycles (59.9%) was performed for egg donation, resulting in the highest yield per cycle, with an average of 10.4 oocytes frozen per cycle. OoC indication was ‘serious disease’ such as cancer in 10.9% of cycles, other medical indications as ‘part of an ART cycle’ in 16.1%, and a non-medical reason in 13.1%. With regard to the use of OoC, the number of specifically recorded frozen oocyte replacement (FOR) cycles performed in 2013 for all medical reasons was 14 times higher than the FOR for non-medical reasons, using, respectively, 8.0 and 8.4 oocytes per cycle. Finally, 12 countries recorded storage following OtC and only 7 recorded the number of grafted frozen/thawed tissues.

LIMITATIONS, REASONS FOR CAUTION

Not all countries have data regarding OoC collection, and some data came from voluntary collaborating centres, rather than a national authority or register. Furthermore, the data related to use of OoC were not included for two major players in the field, Italy and Spain, where numbers were conflated for medical and non-medical reasons. Finally, the number of cycles started with no retrieval is not available. Data are even sparser for OtC.

WIDER IMPLICATIONS OF THE FINDINGS

There is a need for ART authorities and professional bodies to record precise data for practice and use of OoC (and OtC), according to indications and usage, in order to reliably inform all stakeholders including women about the efficiency of both methods. Furthermore, professional societies should establish professional standards for access to and use of OoC and OtC, and give appropriate guidance to all involved.

STUDY FUNDING/COMPETING INTEREST(S)

The study was supported by ESHRE. There are no conflicts of interest.

TRIAL REGISTRATION NUMBER

N/A.

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<![CDATA[Recent developments in genetics and medically-assisted reproduction: from research to clinical applications†‡]]> https://www.researchpad.co/article/5c9e53dfd5eed0c484239b88

Abstract

Two leading European professional societies, the European Society of Human Genetics and the European Society for Human Reproduction and Embryology, have worked together since 2004 to evaluate the impact of fast research advances at the interface of assisted reproduction and genetics, including their application into clinical practice. In September 2016, the expert panel met for the third time. The topics discussed highlighted important issues covering the impacts of expanded carrier screening, direct-to-consumer genetic testing, voiding of the presumed anonymity of gamete donors by advanced genetic testing, advances in the research of genetic causes underlying male and female infertility, utilisation of massively-parallel sequencing in preimplantation genetic testing and non-invasive prenatal screening, mitochondrial replacement in human oocytes, and additionally, issues related to cross-generational epigenetic inheritance following IVF and germline genome editing. The resulting paper represents a consensus of both professional societies involved.

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<![CDATA[Trends over 15 years in ART in Europe: an analysis of 6 million cycles†]]> https://www.researchpad.co/article/5c9e53ebd5eed0c484239ce3

Abstract

Study question

Was the European IVF Monitoring (EIM) Consortium, established in 1999 by ESHRE, able to monitor the trend over time of ART in Europe?

Summary answer

The initial aims of the EIM programme (to collect and publish regional European data on census and trends on ART utilization, effectiveness, safety and quality) have been achieved.

What is already known

ART data in Europe have been collected and reported annually in Human Reproduction.

Study design, size, duration

A retrospective data analysis and summary of the first 15 years of ART activity in Europe (1997–2011) was carried out, using the key figures from the annual ESHRE reports and focusing on how the practice of ART has evolved over the years.

Participants/materials, setting, method

A total of 5 919 320 ART cycles are reported, including IVF, ICSI, frozen embryo relacment and egg donation, resulting in the birth of more than 1 million infants. A total of 1 548 967 IUIs are also reported, including husband/partner’s semen and donor semen cycles. The most relevant and complete data are analysed and discussed.

Main results and the role of chance

With some fluctuations, the number of countries and clinics reporting to EIM increases significantly from 1997 to 2011. A constant increase was also registered in the number of annual cycles reported. Since 2005, the estimation of the EIM coverage on the total European activity was >80%. In countries with 100% of coverage, the mean availability of ART increased from 765 cycles per million inhabitants in 1997 to 1269 cycles per million inhabitants in 2011, and the proportion of ART infants of the total number of infants born in the country increased from 1.3% to 2.4%. The proportion of women aged > 39 years undergoing IVF and ICSI cycles gradually increased. For 12 consecutive years, the proportion of ICSI versus IVF cycles showed a marked increase before reaching a plateau from 2008. The proportion of transfers with three or more embryos decreased constantly and the proportion of SETs increased over the time period. The triplets deliveries were reduced from 3.7% in 1997 to less than 1% since 2005 (0.6% in 2011). The effectiveness (evaluated as clinical pregnancy rate per aspiration and per embryo transfer) increased until 2007, then the figure remained stable. The cumulative percentage of documented pregnancy losses was 17%. No differences have been noted in terms of outcomes in the IUI cycles.

Limitations, reasons for caution

The data presented are accumulated from countries with different collection systems, regulations, insurance coverage and different practices. Each year a number of countries have been unable to provide some of the data.

Wider implications of the finding(s)

The first summary of 15 years of the EIM reports offers interesting data on census and trends on ART utilization, safety and quality in Europe. The primary aim of the ESHRE effort in supporting European data collection has been reached. Owing to its importance inside and outside the professional community, European data collection and publication on ART have to be supported and implemented.

Study funding/competing interest(s)

None.

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<![CDATA[Recommendations for the Surgical Treatment of Endometriosis. Part 1: Ovarian Endometrioma†‡¶]]> https://www.researchpad.co/article/5c9e53efd5eed0c484239d36

Abstract

STUDY QUESTION

What does this document on the surgical treatment of endometriosis jointly prepared by the European Society for Gynaecological Endoscopy (ESGE), ESHRE, and the World Endometriosis Society (WES) provide?

SUMMARY ANSWER

This document provides recommendations covering technical aspects of different methods of surgery for endometriomas in women of reproductive age.

WHAT IS ALREADY KNOWN

Endometriomas (ovarian endometriotic cysts) are a commonly diagnosed form of endometriosis, owing to the relative ease and accuracy of ultrasound diagnosis. They frequently present a clinical dilemma as to whether and how to treat them when found during imaging or incidentally during surgery. Previously published guidelines have provided recommendations based on the best available evidence, but without technical details on the management of endometriosis.

STUDY DESIGN SIZE, DURATION

A working group of ESGE, ESHRE and WES collaborated on writing recommendations on the practical aspects of endometrioma surgery.

PARTICIPANTS/MATERIALS, SETTING, METHODS

This document focused on endometrioma surgery. Further documents in this series will provide recommendations for surgery of deep and peritoneal endometriosis.

MAIN RESULTS AND THE ROLE OF CHANCE

The document presents general recommendations for surgery of endometrioma, and specific recommendations for cystectomy, ablation by laser or by plasma energy, electrocoagulation and a combination of these techniques applied together or with an interval between them.

LIMITATIONS REASONS FOR CAUTION

Owing to the limited evidence available, recommendations are mostly based on clinical expertise.

WIDER IMPLICATIONS OF THE FINDINGS

These recommendations complement previous guidelines on the management of endometriosis.

STUDY FUNDING/COMPETING INTERESTS

The meetings of the working group were funded by ESGE, ESHRE and WES. C.B. declares to be a member of the independent data monitoring committee for a clinical study by ObsEva, and receiving research grants from Bayer, Roche Diagnostics, MDNA Life Sciences, and Volition. E.S. received honoraria for provision of training to healthcare professionals from Ethicon, Olympus and Gedeon Richter. The other authors declare that they have no conflict of interest.

TRIAL REGISTRATION NUMBER

NA.

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