31 January 2022
Director of the Progress Educational Trust and commissioning editor of its flagship publication BioNews
There has been much professional and public debate about the use of so-called fertility treatment 'add-ons' over the years. The Progress Educational Trust's event 'Adding Up What We Know: A Global Perspective on Fertility Treatment Add-Ons' brought together an international lineup of speakers to share their knowledge and broaden the discussion.
Dr Kersti Lundin director of Sahlgrenska University Hospital's Reproductive Medicine Laboratory, and co-chair of the European Society for Human Reproduction and Embryology (ESHRE)'s working group on add-ons opened the discussion by setting out what add-ons are. They are something 'not essential for treatment, but optional interventions added on top, most often at an additional cost' she said.
Dr Lundin explained that there are a wide range of treatment add-ons on offer; including different tests, drugs, holistic or alternative therapies, 'special' equipment, laboratory techniques and surgical interventions. It is claimed that these improve pregnancy or live birth rates, reduce the risk of miscarriage, or shorten the time to pregnancy.
ESHRE has set up a working group to produce recommendations for professionals, patients and policymakers, with the aim of ensuring that all fertility patients receive safe and evidence-based treatment. Some 33 add-ons have been identified and stratified into different categories diagnostic tests, laboratory interventions, clinical management and 'selective' add-ons. Dr Lundin said that 'selective' add-ons were treatments which are clinically appropriate for some patients for example, intracytoplasmic sperm injection (ICSI) for male factor fertility which should not be used for all patients.
The next panellist was Dr Manuela Perotta, a senior lecturer in technology and organisation at Queen Mary University of London and principal investigator at the Remaking the Human Body project (which is funded by Wellcome). Dr Perotta presented some of the findings from this project.
Anyone still in any doubt about the proliferation of add-ons would have those doubts pushed aside on hearing the results of a survey that Dr Perrotta and her team had carried out. Patients reported on the add-ons they had used, been offered or considered using. She showed a very busy word cloud which listed around 60 procedures believed by some to be add-ons, ranging from endometrial scratch to DNA karyotyping.
The focus of Dr Perrotta's talk was differences in perceptions of add-ons between professionals, patients and patients' partners. Some professionals considered something to be an add-on depending on whether and how it was itemised on the bill given to a paying patient, while others thought there should be distinctions as to how an add-on was regulated depending on how invasive the particular treatment was.
There were very wide-ranging findings when it came to patients' perceptions. Some patients extensively researched add-ons and sought them out, while others wanted to delegate decisions about their treatment including add-ons to the medical professionals. The postcode lottery relating to state funding of fertility treatment leads to some NHS patients being treated in private clinics and some self-funded patients being treated in NHS clinics, making it yet more difficult to decide what is and isn't an add-on in the UK. Furthermore, if a patient has only a very limited opportunity for state-funded treatment, then they are understandably liable to try everything possible to help the treatment work.
Dr Perrotta discussed the Human Fertilisation and Embryology Authority (HFEA)'s traffic light system for assessing add-ons. Her research had uncovered a number of issues for patients with the current system perhaps most significantly, the fact that many of them are not aware of it. Other patients did find the HFEA's information during the course of their extensive online research, but even then, they did not necessarily feel equipped to evaluate the advisability of add-ons in their specific situation.
Dr Perrotta argued that the HFEA's traffic lights need to be more visible, need to present information about other relevant criteria besides live birth rates (for example, of miscarriage rates) and should make it possible for patients to explore multiple layers of information about evidence.
We moved from the UK to Australasia with the next speaker, Dr Sarah Lensen an editor at Cochrane's Gynaecology and Fertility Group, where she was responsible for the Cochrane Special Collection 'IVF: Effectiveness of Add-Ons and Research', and also a research fellow at the University of Melbourne. Australia has one of the highest uses of IVF per capita in the world, with just over 2600 cycles per million per year being carried out. There is however, little data relating to add-ons from the Australia and New Zealand Assisted Reproduction Database.
Dr Lensen and her team investigated the add-ons by assessing clinic websites in Australia and New Zealand, and found that 78 percent of clinic websites offered add-ons. There were 21 different add-ons on offer (using these researchers' definition of an add-on), the cost of which ranged from no extra charge to around 2000. PGT-A, time lapse and assisted hatching were the add-ons most commonly listed, and most descriptions of add-ons contained statements about the add-ons' supposed benefits.
A patient survey relating to the prevalence, offer and use of add-ons was then carried out. There were 1600 responses, and 82 percent of respondents had used an add-on. The most commonly used add-on was acupuncture specifically intended to accompany fertility treatment (see BioNews 1107), followed by PGT-A and Chinese herbal medicine. Most people who had used an add-on had heard about it from their fertility specialist, who raised it during a consultation.
Dr Lensen concluded her presentation with some interesting research on the use of endometrial scratch. In 2015, her team found that 83 percent of clinicians offered endometrial scratch, with 73 percent believing it to be beneficial for recurrent implantation failure. During the intervening years, the use of endometrial scratch has not been backed up by evidence. Research carried out in 2020 showed that only 34 percent were now offering this treatment, with 24 percent believing it to be beneficial (see BioNews 1126).
Back to Europe for the next speaker, Satu Rautakallio-Hokkanen, who is chair of Fertility Europe (an umbrella group of 26 fertility patient organisations) and also secretary of Infertility Association Simpukka (which is based in Finland). She gave the all-important patient perspective, which is key to understanding the use and prevalence of add-ons. We learned how despair, ignorance and desperation for information feed into the uptake of add-ons. Rautakallio-Hokkanen and colleagues had conducted a survey which found that 55 percent of patients found out about add-ons from the internet, and 93 percent wanted to find out more about them. The main driver, she suggested, is that add-ons provide hope.
Worryingly, 49 percent stated that they didn't know or didn't understand the benefits of the relevant add-on, but still wanted to try it. More worryingly still, 65 percent could not say whether they thought the add-on was safe or not. Rautakallio-Hokkanen called for more respect to be shown to patients and an end to the exploitation of their despair. Patients need proven treatments and an honest discussion about the risks and benefits, she said.
Next we hopped over the pond to the USA, to hear from Dr Sigal Klipstein chair of the American Society for Reproductive Medicine (ASRM)'s Ethics Committee, and an obstetrician/gynaecologist at InVia Fertility in Chicago.
Dr Klipstein outlined the recent publication Moving Innovation to Practice, in which the ASRM Ethics Committee emphasises that evidence of safety and effectiveness is necessary, before dissemination of new interventions into clinical practice. Dr Klipstein said that the key question for patients should be 'Will this particular treatment benefit me?'. She said that some patients feel lucky to stumble upon the only clinic that offers 'treatment X', but they should question this if treatment X is so great, why aren't more clinics offering it? She used an amusing made-up study to illustrate how easily studies can be skewed by small sample sizes and cherrypicking patient groups.
Dr Klipstein concluded by challenging the audience with a series of fundamental questions. If a patient asks for an add-on and is willing to pay, and their doctor acquiesces, is this acquiescence tantamount to implicit approval? Does it give false hope or? Conversely, if the doctor declines to offer the requested treatment, is this paternalistic? Or is it actually good medical care?
The final speaker was Peter Thompson, chief executive of the HFEA. He welcomed the fact that there is now more global discussion of add-ons than was previously the case, with different professional bodies taking an interest. What the HFEA aims to do, he said, is to provide impartial and independent evidence and information on add-ons for professionals and patients. One of the major challenges has been how to explain complex and subtle issues in a simple but meaningful way, such that it is accessible.
The HFEA's current traffic light system rates 11 add-ons, and assesses add-ons according to one key criterion - is the treatment under consideration proven to be effective, for most fertility patients, in increasing their chances of having a baby?
The HFEA is looking at reviewing and refining the traffic light system, and will be carrying out a consultation on this in future. As there are currently no 'green' rated add-ons listed on the HFEA website, this may lead some patients to view an 'amber' rating as a recommendation, rather than (as is intended) a warning to be cautious. So perhaps changes in presentation are warranted. Another area that Thompson mentioned reviewing was the evidence base used for the rating system - this relies on randomised controlled trials, which is arguably problematic when there is a dearth of such trials. The final consideration is whether to change the measure of success from improving the live birth rate to reducing miscarriage, or reducing time to pregnancy.
After these opening presentations, the audience asked questions about whether and when ICSI should be considered an add-on, a lack of awareness among patients of the risks posed by some add-ons, and the fact that some patients are not even aware that they are using an add-on. There was clear agreement among the speakers that it should not be the responsibility of the patient to ask about risks.
One of the main take-home messages was the need for shared decision-making, so that while patients' voices are heard and taken into account, doctors do not abrogate their responsibility. Fertility doctors must be prepared to give patients unpalatable advice, about why certain treatments may not be appropriate.
PET is grateful to the team at the Remaking the Human Body project (which is based at Queen Mary University of London and funded by Wellcome) for supporting this event. Our next online events will be:
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Adding Up What We Know: A Global Perspective on Fertility Treatment Add-Ons - BioNews
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