29 research outputs found

    Adjuncts in the IVF laboratory: where is the evidence for ‘add-on’ interventions?

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    Globally, IVF patients are routinely offered and charged for a selection of adjunct treatments and tests or ‘add-ons’ that they are told may improve their chance of a live birth, despite there being no clinical evidence supporting the efficacy of the add on. Any new IVF technology claiming to improve live birth rates (LBR) should, in most cases, first be tested in an appropriate animal model, then in clinical trials, to ensure safety, and finally in a randomized controlled trial (RCT) to provide high quality evidence that the procedure is safe and effective. Only then should the technique be considered as ‘routine’ and only when applied to the similar patient population as those studied in the RCT. Even then, further paediatric and long-term follow up studies will need to be undertaken to examine the long-term safety of the procedure. Alarmingly, there are currently numerous examples where adjunct treatments are used in the absence of evidence-based medicine and often at an additional fee. In some cases, when RCTs have shown the technique to be ineffective, it is eventually withdrawn from the clinic. In this paper, we discuss some of the adjunct treatments currently being offered globally in IVF laboratories including embryo glue and adherence compounds, sperm DNA fragmentation, time lapse imaging, preimplantation genetic screening, mitochondria DNA load measurement and assisted hatching and examine the evidence for their safety and efficacy in increasing LBRs. We conclude that robust studies are needed to confirm the safety and efficacy of any adjunct treatment or test before they are offered routinely to IVF patients

    ESHRE's key research priorities in infertility: maximizing impact on science, people and society

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    STUDY QUESTION Which research topics in the area of infertility should be prioritized in the allocation of research resources? SUMMARY ANSWER Twelve research priorities were formulated, spanning the following areas: preventing infertility and preserving fertility, gynaecological diseases, male infertility, optimizing fertility treatments, optimizing psychosocial support and deepening knowledge on preimplantation development and early pregnancy. WHAT IS KNOWN ALREADY Many research gaps related to infertility and its management remain understudied and underfunded, making it important to set priorities to ensure appropriate allocation of research resources. STUDY DESIGN, SIZE, DURATION The European Society of Human Reproduction and Embryology (ESHRE) appointed a multidisciplinary working group, including a patient representative, to develop a list of research priorities related to infertility, which are relevant to researchers and institutions that fund research. PARTICIPANTS/MATERIALS, SETTING, METHODS A list of research topics was collated based on the recommendations for future research formulated in ESHRE’s evidence-based guidelines and suggestions submitted by ESHRE’s Special Interest Groups as call topics for the ESHRE research grants. A scoring tool was developed to assess the expected impact of research on each topic on individuals, society and scientific advancement. Topics were scored independently by the working group members and the 12 topics with the highest scores were selected for presentation in this paper. MAIN RESULTS AND THE ROLE OF CHANCE Using our newly developed scoring tool, we have identified 12 research priorities that broadly fall under six areas. These are preventing infertility and preserving fertility, gynaecological diseases, male infertility, optimizing fertility treatments (two priorities per area selected), optimizing psychosocial support (one priority selected) and deepening knowledge on preimplantation development and early pregnancy (three priorities selected). LIMITATIONS, REASONS FOR CAUTION The impact scoring tool would benefit from further testing and refinement in future projects. The scoring of some impact indicators is heavily based on the judgment and expertise of the scorers, which was accounted for by ensuring representation of knowledge and experience from all relevant disciplines and subject areas as well as the patient perspective within the working group. WIDER IMPLICATIONS OF THE FINDINGS This paper may serve to stimulate further thought and discussion within the infertility research community on the potential impact of proposed and ongoing research. It will furthermore inform and encourage policy makers involved in research funding allocation and contribute to a more efficient and purposeful allocation of research resources towards infertility research. STUDY FUNDING/COMPETING INTEREST(S) The technical support for this project was provided by ESHRE. A.C. reports employment at Juno Genetics. Y.C. reports a grant from Guerbet and honoraria from Ferring, Merck, Abbot, Nordic Pharma and Organon. G.C. reports consulting fees from Gedeon Richter and honoraria from Cooper Surgical. S.G. reports the development of www.myjourney.pt licensed under a CC BY-NC-SA 4.0 licence. J.K.-B. reports grants from the NIHR Evaluation and Studies Coordinating Centre, the Gates Foundation, the Economic and Social Research Council, BAYER Consumer Health and MRC Confidence in Concept; honoraria from Ferring and Cooper Surgical; travel support from Ferring, Cooper Surgical, Congressworks LLP, Deutsche Gesellschaft für Andrologie e. V., BAYER, University of Munster and ESHRE; a patent for microchannel sperm cell preparation; and a leadership or fiduciary role in the Association of Clinical and Reproductive Scientists. A.P. reports grants (to her institution) and consulting fees from Gedeon Richter, Ferring, Merck A/S and Cryos; honoraria from Gedeon Richter, Ferring, Merck A/S and Organon; and travel support (to her institution) from Gedeon Richter. H.S.N. reports grants from Freya Biosciences ApS, Ferring Pharmaceuticals, BioInnovation Institute, Ministry of Education, Novo Nordic Foundation, Augustinus Fonden, Oda og Hans Svenningsens Fond, Demant Fonden, Ole Kirks Fond and the Independent Research Fund Denmark; speaker’s fees from Ferring, Merck A/S, Astra Zeneca, Cook Medical, Gedeon Richter, Ibsa Nordic, Novo Nordisk A/S; co-development of an app with the Maternity Foundation; and co-founding a project with Lulu Health. The remaining authors (J.T., A.A., I.D., C.F., M.G., A.S.L., M.M.-R., V.N., A.O., N.R., M.S.-L., P.T., N.V., S.V. and K.S.) have nothing to declare. TRIAL REGISTRATION NUMBER N/

    Human embryo research in France

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    opinionhttp://dx.doi.org/10.1093/humrep/17.2.26
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