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Claims for fertility interventions: a systematic assessment of statements on UK fertility centre websites
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  • Published on:
    Re: Lack of evidence for interventions offered in UK fertility centres
    • Carl Heneghan, Professor of Evidence-Based Medicine University of Oxford

    To The Editor, BMJ

    Dear Dr Godlee

    Balen et al have responded to our papers. [1,2] In our BMJ open paper we systematically identified 276 claims of benefit relating to 41 different fertility interventions and 16 published references were cited 21 times on 13 of the 74 websites we searched.[1] In our BMJ analysis paper, we systematically examined the evidence for ‘38 additional fertility interventions’ and found evidence of improvements in live birth rates for only five interventions. We used standard critical appraisal techniques (as detailed in our paper) to explore the quality of these studies. We identified that for all five of these interventions the studies had methodological problems, raising uncertainty about the significance of the results. This is a serious issue for patients, public health, public trust, and regulators.

    Balen et al suggest that our evidence review included - and found evidence lacking for - things which are not “add-ons”. We classified ‘add-ons’ in the BMJ analysis article in response to peer review where the issue was discussed (see online peer review comments).

    Peer review comment: ‘The methodology has led them to five interventions for which there may be some evidence of improvement in live birth rates. One of these is intrauterine insemination in a natural cycle. This is an alternative treatment, rather than an “add-on”, and usually not one applied to the population who require IVF, and certainly not one intended to...

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    Conflict of Interest:
    Competing interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following: CH has received grant funding from WHO, the National Institute for Health Research (NIHR), and the NIHR School of Primary Care and occasionally receives expenses for teaching evidence based medicine. He jointly runs the EvidenceLive Conference with BMJ, is Editor in Chief of the BMJ Evidence-Based Medicine Journal and receives payment as an NHS GP in urgent care. BG has received research funding from the Laura and John Arnold Foundation, the Wellcome Trust, the NIHR, the Health Foundation, and WHO; he also receives personal income from speaking and writing for lay audiences on the misuse of science. KM has received funding from the NIHR and the RCGP for independent research projects. The views expressed here are those of the authors and not necessarily those of any of the affiliated institutions mentioned in the manuscript.
  • Published on:
    Note from the Editor in reference to the response from Dr Adam Balen

    The response below should have been posted in January 2017. It responds both to this BMJ Open article and to a related article in The BMJ (http://www.bmj.com/content/355/bmj.i6295). It was posted on bmj.com on January 18 2017 but failed to be replicated within BMJ Open. We apologise for this. The authors have been asked to respond.

    Conflict of Interest:
    I am the Editor of BMJ Open.
  • Published on:
    Lack of evidence for interventions offered in UK fertility centres
    • Adam Balen, Professor of Reproductive Medicine and Surgery Leeds Centre for Reproductive Medicine

    To The Editor, BMJ

    Dear Dr Godlee

    Re: Lack of evidence for interventions offered in UK fertility centres.

    We are writing to express our concern regarding the papers by Heneghan et al, (2016) and Spencer et al (2016) owing to their lack of scientific robustness.

    We would like to state at the outset that we oppose the provision of procedures or treatments that do not have a scientific basis and we welcome the initiative by the Human Fertilisation and Embryology Authority (HFEA), which has been endorsed by the British Fertility Society (BFS), to introduce a grading scheme for “add-ons”.

    Spencer, Heneghan and colleagues have unfortunately obscured their important message by mixing various categories of treatment, not all of which come under the category of “add-ons”. Indeed, a number are accepted components of routine treatment. The papers have grouped together three categories of care: (i) necessary investigations (e.g. assessment of ovarian reserve, which is vital in determining correct dosage of ovarian stimulation drugs to optimise outcome and ensure patient safety), (ii) essential treatments (e.g. surgical sperm retrieval) and (iii) interventions that can be termed “add-ons” - namely an addition to a pathway of care, whether as an additional drug or therapeutic procedure. Many of the items identified have a clearly defined role in specific situations; e.g. for a man with a physical blockage sperm has to be extracted surgically, frozen an...

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    Conflict of Interest:
    Competing interests: Adam Balen: NHS Consultant in Reproductive Medicine and Clinical lead for the Leeds Centre for Reproductive Medicine, which performs all fertility treatments funded by the NHS. Partner in Genesis LLP, the private arm of the Leeds Centre for Reproductive Medicine, which performs self-funded fertility treatments using identical protocols to the NHS. Chair, British Fertility Society. Chair, NHS England IVF Pricing Development Expert Advisory Group. Chair, World Health Organisation Expert Working Group on Global Infertility Guidelines: Management of PCOS. Consultant for ad hoc advisory boards for Ferring Pharmaceuticals, Astra Zeneca, Merck Serono, Gideon Richter, Uteron Pharma. Research funding received in the past--Pharmasure / IBSA (Key note lecture at ESHRE 2016 & hospitality to attend meetings); OvaScience (Member of international ethics committee);Clear Blue (National medical advisory board); IVI, UK (Chair, Clinical Board). Raj Mathur: I have an NHS and Private practice where I see patients undergoing assisted conception treatment. Anthony J Rutherford: Consultant in Reproductive Medicine, working in a combined NHS & Private IVF unit at Leeds Teaching Hospitals NHS Trust, and Medical Director & Personal Responsible of a private IVF unit, IVI Wimpole Street, London. • Clinical Member of the Human Fertilization & Embryology Authority • My wife works as a Clinic Development Manager for Pharmasure, a Pharmaceutical Company involved in Reproductive Medicine. Harish Bhandari: Junior Clinicians' representative on the British Fertility Society Executive Committee and a co-opted member on the British Fertility Society's Training Sub-Committee. Darren K Griffin: Treasurer of the Preimplantation Genetic Diagnosis International Society (PGDIS) and holder of 2 grants part sponsored by the London Women’s Clinic and Genesis Genetics to investigate PGS. James Hopkisson: Consultant in Reproductive Medicine, working in an NHS Hospital Trust, as a clinical academic. Medical Director & Person Responsible to the HFEA and CQC of a private IVF unit NURTURE Fertility that provides treatment to both NHS and self funding patients. I am a shareholder in NURTURE LLP and Burton Fertility. Susan Seenan: Employed as CE of patient charity Fertility Network UK. Ian Aird: Clinical member British Fertility Society. I have received sponsorship from pharmaceutical and reproductive science industry to cover travel and accommodation costs to attend scientific meetings and symposia. Geoffrey H Trew: Consultant in Reproductive Medicine Imperial College NHS Trust. Director TFP. Jason Kasraie: 1) Consultant Embryologist & Andrologist (Clinical Scientist) and HFEA Person Responsible at the Shropshire & Mid-Wales Fertility Centre, Shrewsbury & Telford Hospitals NHS Trust. 2) Chair of the Association of Clinical Embryologists. Allan Pacey: Principal applicant of research grant awards from the Medical Research Council and the National Institute for Health Research (with funds awarded to the University of Sheffield). Engaged as a consultant by the British Broadcasting Corporation, Merck Serono Limited, Swiss Precision Diagnostics Development Company, PZ Media, Purple Orchid Pharma Ltd., and the World Health Organisation (with all monies and expenses paid to the University of Sheffield). Unpaid roles as: (i) Editor in Chief of Human Fertility; (ii) Chairman of the Andrology Specialist Advisory Group of theUnited Kingdom National External Quality Assessment Service (UK NEQAS); and (iii) trustee of the Progress Educational Trust. Nick S Macklon: Non-executive director, Anecova. Jane Stewart: Full time NHS consultant in reproductive medicine. Our unit also treats self-funded patients. Honorary secretary, British Fertility Society. Simon Fishel: Shareholder in CARE Fertility. Ian Cooke: Consultant to the WHO. Chair of the Trustees of the British Fertility Society. Grace Dugdale: Temporary freelance work for the British Fertility Society; Developing educational resources Oct 2016-present. Sheena E M Lewis: Professor Emeritus of Reproductive Medicine, Queen’s University Belfast. Chair, British Andrology Society. National representative for UK, European Society Human Reproduction and Embryology. Recipient of funding from NIHR and Marie Curie Initial Training Network. Member of HFEA SCAAC. Ad Hoc speaker for Science Media Centre. Director of University spin out company, SpermComet Ltd. Ephia Yasmin: I am a Consultant Obstetrician and Gynaecologist at University College London Hospital. I work as a consultant at IVI-UK. I am on the scientific advisory board of Ferring Pharmaceuticals. Bart C J M Fauser: During the most recent 5 year period B.C.J.M.F. has received fees and grant support from (in alphabetic order); Actavis/Watson/Uteron, Controversies in Obstetrics & Gynecology (COGI), Dutch Heart Foundation, Dutch Medical Research Counsel (ZonMW), Euroscreen, Ferring, London Womens Clinic (LWC), Merck Serono (GFI), Netherland Genomic Initiative (NGI), OvaScience, Pantharei Bioscience, PregLem/Gedeon Richter/Finox, RBM Online, Roche, Teva, World Health Organisation (WHO). C Janine Elson: Paid member of Finox Advisory Board. Received travel and accommodation expenses from Pharmasure. Joshua D Blazek: I am employed by industry and am a member of PGDIS, COGEN, and ASRM. All other signatories: None declared.
  • Published on:
    Dangerous IVF tourism abroad

    Online resources predicting the chances of a live birth will educate women and help them avoid unnecessary or even harmful IVF cycles. IVFs are cost effective up to age 43, according to NICE. [1] Ovarian and uterine cancers are increased 4-fold and 5-fold respectively, after IVF treatment, as this excellent long term follow up study of tens of thousands of women clearly demonstrated. [2][3] Serious and debilitating health consequences later on should be remembered when calculating additional benefits of continuing IVF cycles.

    Irresponsible IVF Clinics abroad offer luring fertility tourism packages to UK patients rejected at home, even to women older than 50. [4][5][6] Very few women will proceed in such costly practices, especially after they are correctly and ethically informed about long term health consequences.

    References
    [1] http://www.bmj.com/content/344/bmj.e3656
    [2] http://link.springer.com/article/10.1007%2Fs00432-015-2035-x#
    [3] http://www.ncbi.nlm.nih.gov/pubmed/26337160
    [4] http://www.independent.co.uk/life-style/health-and-families/health-news/...
    [5]...

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    Conflict of Interest:
    None declared.
  • Published on:
    NICE guidelines fail to provide evidence on first line fertility treatment
    • Gulam Bahadur, Consultant Clinical Andrologist
    • Other Contributors:
      • G. Bahadur, B Woodward, R. Homburg, A. Al-Habib, A Muneer

    We note the recommendation that NICE together with HFEA should provide fertility guidance on what is offered (1). Although HFEA have no legal jurisdiction in providing guidance, NICE have failed to address several important points in the evidence review for first line treatment options (2). The original NICE document proposing that IVF should be offered over intrauterine insemination (IUI) was controversial to such an ex...

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    Conflict of Interest:
    None declared.