Sarah Milosevic
I hope that society wakes up to this silent crisis in women’s health happening all around us (1)
Issues in IVF, such as unproven treatment add-ons and the postcode lottery for funding, have been prominent in the news in recent years. What is little discussed – and arguably more insidious – is that trustworthy, evidence-based information for IVF patients is so difficult to access, that in many cases informed consent for treatment is not being obtained.
A survey commissioned by the Royal College of Obstetricians and Gynaecologists (RCOG) (2) found that 86% of women had encountered contradictory information about fertility from different sources, and 76% could not be sure that fertility information was impartial and unbiased.
When going through fertility treatment it can feel like clinics are the merchants of hope, but if different specialists are telling you, and selling you, different things, deciding what to do can be overwhelming. There’s also a wealth of weird, wonderful and downright crazy stuff to try, that someone on the internet swears worked for them, which of course you end up doing, because you’re desperate – and don’t want to feel guilty that you didn’t try hard enough. (IVF patient) (3)
A recent qualitative study exploring communication in IVF (4) found patient information provision was not always sufficient to enable informed consent. Even patients who initially believed they had received sufficient information reported being unprepared for the reality of treatment.
IVF in the UK
Globally, around 1 in 6 people are affected by infertility (5). In 2021, around 50,000 women underwent IVF in the UK, a number that is increasing year-on-year (6). The process involves multiple hormone injections, with side effects including hot flushes, headaches, mood swings – and in rare cases ovarian hyperstimulation syndrome (7). The psychological impact is also considerable. In a 2022 UK survey of patients experiencing fertility problems and/or treatment, 83% reported emotional distress, 47% regular feelings of depression and 40% suicidal thoughts (8). Most patients pay privately for IVF (6), spending on average £13,750 in 2022 (8), causing financial difficulties for many.
Our mental health is at an all-time low. My husband is working 16 hours a day sometimes to try and keep us afloat. We don’t know if we will ever be able to be parents… It’s a pain you cannot even begin to describe, a constant ache in your heart like no other. (IVF patient, p.11) (9)
IVF misinformation
Misinformation surrounding IVF is highly prevalent. A 2022 review of fertility clinic advertising by the Competition and Markets Authority (10) found the majority did not comply with consumer law. Issues identified included a lack of transparency in pricing, misleading success rates and inadequate information about the evidence base for treatment add-ons.
Three-quarters of UK clinics offer add-ons (11) – optional extra treatments claimed to increase the probability of a successful pregnancy (such as assisted hatching or endometrial scratching) – yet none have been shown to be effective in increasing pregnancy rates, with several potentially reducing the chance of success (12). The impact on patients can be profound, including substantial financial costs, feelings of regret (13) and potential health risks (14).
Having personally experienced IVF, I argue that the provision of trustworthy, evidence-based patient information would help counter the effects of misinformation, reduce patient stress and ensure informed consent can be given.
Taking an evidence-based approach
As a health researcher starting IVF treatment for the first time, I was aware of the limited evidence base around IVF add-ons, and of the wide range of misinformation circulating on the internet. With complete trust that the NHS would provide me with the information I needed, I decided at the outset to follow the evidence, solely adhering to what was recommended to me by health professionals. I ignored online forum posts describing the cocktail of expensive supplements some of my peers were taking, instead studying the detailed (colour!) booklet I had been given by my NHS clinic, that contained all the information I thought I needed. What I hadn’t realised, is just how complex it would be to navigate the system and find complete, reliable information.
Undergoing IVF
Taking the medication
The first part of my treatment involved daily hormone injections. Heading to my clinic appointment a few days before, I naively wondered how the injection teaching session would go – perhaps starting by injecting oranges? In reality, the 15-minute appointment was mainly spent completing paperwork, the injections only having a brief mention, with the nurse telling me to follow the instructions on the box, and search for videos on YouTube if I got stuck. An international study of IVF patients found 80% of UK participants worried about correctly administering injections – the highest of seven countries surveyed – with only 15% of UK clinicians regarding their patients as being concerned (15). 45% of patients believed they had made an error in administering injections, most commonly regarding dosage or timing, with 17% worrying this may impact negatively on their treatment outcome (15).
Injections and egg retrieval completed, with four embryos in the freezer, I started preparation for embryo transfer. I had experienced minimal side effects until that point, but taking oestrogen was a different story. Effectively HRT – but around four times the dose prescribed to menopausal women – the oestrogen tablets made me feel too sick to eat more than a few crackers a day. After two weeks, having had no advice from my clinic other than a leaflet about common side effects, I turned to searching online forums for help, coming across the suggestion to try oestrogen patches instead. To my surprise, when I arrived at my next appointment ready to argue my case, all I had to do was ask, and a prescription for patches was duly handed over. After I switched, the side effects disappeared almost instantly.
Research suggests that using oestrogen hormone therapy patches rather than tablets is lower risk (16) and associated with fewer side effects (17). Yet they were not proactively offered as an alternative option, and I would have been unaware of them had it not been for the online forum. NICE (National Institute for Health and Care Excellence) guidelines (18) state that all patients should be given the opportunity to be involved in decision-making about prescribed medicines, with open discussion of the pros and cons and possible side effects. Although most UK patients report general satisfaction with their involvement in IVF decision-making (19), the level of joint decision-making around medications is not known.
Transferring the embryo
Preparing for my first embryo transfer involved daily injections to suppress natural hormones, followed by oestrogen tablets to thicken the womb lining, then twice-daily progesterone pessaries to support it, that I would need to take for the first trimester of pregnancy. Overall potentially around four months of hormone treatment, with associated side effects. What I wasn’t told, was that there was another option.
My first embryo transfer failed, and back on the online forums, I noticed some women mentioning a natural embryo transfer cycle. This had not been offered by my clinic, but looking into it, I found it was suitable for women with regular ovulatory cycles – and involved no medication at all. It is also considerably quicker, an important consideration as I was aware of my ever-ticking biological clock.
At my follow-up consultant appointment, it was agreed – again with no argument – that I could try a natural transfer cycle. This was a far better experience, and I continued the approach for the remainder of my IVF treatment. But in practice I found the clinic nurses were very reluctant to allow it, as it made the cycle more difficult to schedule. I had to strongly argue my case each time, sometimes phoning up on several occasions until I found a nurse who agreed. It is suggested (20) that medicated transfer cycles are ‘commonly used to optimize patient flow and staff resources regardless of the ovulatory status of patients’ (p. 1).
NICE guidelines (21) state that women with regular ovulatory cycles should be advised that natural cycle frozen embryo transfers have a similar success rate to hormone-supplemented transfer cycles. However, evidence suggests this guidance is not being implemented. In November 2023, I sent a Freedom of Information (FOI) request to all NHS IVF clinics, to find out the proportion of frozen embryo transfer cycles being carried out naturally. Of 5,437 frozen embryo transfer cycles across the 19 clinics that responded (for the most recent year they had data), just 455 (8.4%) were natural, and only 9 clinics mentioned natural transfer cycles in their patient information sheet. Therefore, it is likely that a considerable number of patients are not being made aware of this route.
After finally becoming pregnant following my fifth embryo transfer, I was automatically placed under consultant-led care, told that this was because IVF pregnancies were higher risk. Keen to transfer to midwife-led care, I looked into the evidence for this. I was shocked to discover that hormone-supplemented embryo transfer cycles increase the risk of adverse outcomes for both mother and baby. A recent systematic review and meta-analysis (22) found they are associated with significantly higher rates of pre-eclampsia, hypertension, postpartum haemorrhage, macrosomia and preterm birth. The authors conclude that natural transfer cycles are safer for the mother and baby, and should be the preferred treatment for women with regular ovulatory cycles (22).
Fortunately, I had become pregnant following a natural transfer cycle and was able to move to midwife-led care. With hindsight, I do not feel that I gave informed consent for my first hormone-supplemented embryo transfer cycle, as I was not told of the increased risk, or even that an alternative option existed. The Human Fertilisation and Embryology Authority (HFEA) Code of Practice states that IVF centres should give patients information about ‘the potential immediate and longer-term risks of the treatment… [and] the nature and potential risks of any alternative treatment options available so the patient can make an informed decision’ (p.31) (23). The responses to my FOI request clearly indicate that this is not happening in practice.
The need for change
My own experience – backed up by the published research (2, 4), NHS clinic data and reviews of patient information – points to a substantial issue with evidence-based patient information and informed consent in IVF.
General Medical Council guidance on informed consent states that doctors must ‘give patients clear, accurate and up-to-date information, based on the best available evidence, about the potential benefits and risks of harm of each option’ (p.14) (24). By this definition, informed consent in IVF is failing at every level. Women are struggling to access accurate, unbiased information (2), with the majority of IVF clinics making claims that are not evidence-based, failing to comply with consumer law (10). Furthermore, reviews of NHS clinic data and patient information indicate that women are not being offered the full range of treatment options, or information about relative risks and benefits.
Increasingly, patients are turning to the internet for information, with use of online forums as a source of fertility treatment information and support rising from 33% in 2018 to 56% in 2021 (19). However, online communities for those experiencing infertility can be a double-edged sword – on the one hand providing helpful information, and on the other disseminating inaccuracies (25). While they may be useful for mutual support, and tips for surviving the two-week wait leading to a pregnancy test, they should not be needed to plug the gap in medical information provision from IVF clinics.
Barriers to change
Time and inconvenience
A major barrier to patients receiving sufficient information to enable informed consent is the time and inconvenience cost to IVF clinics. Providing information about treatment options, benefits and risks, and discussing potential side effects is time-intensive, with appointment length a significant predictor of clinician information provision (26). In 2021, 22% of privately-funded fertility patients were not satisfied with their involvement in treatment conversations and decision-making, increasing to 30% of NHS-funded patients (19). Higher levels of patient-centred care in IVF are significantly associated with greater quality of life and lower levels of depression and anxiety (27). Unfortunately, a one-size-fits-all approach is more time- and cost-effective than providing alternative options.
We were not treated as individuals and a care plan was not discussed with us. There seemed to be a lot of assumptions made by clinical staff and the consultants had no empathy or compassion at all. (IVF patient) (19)
Translating research into practice
A further barrier to change is the length of time it takes for the latest research to be translated into practice and to be included in patient information, particularly as many patients have a time-limited opportunity for success. The problems with this are twofold – firstly, patients are left to interpret new evidence themselves, and secondly, this understandably leads some to reason that as-yet unproven treatments may potentially be effective (28).
IVF as a luxury
IVF is still seen as a luxury by many. Less than half of UK adults are in favour of IVF being freely available on the NHS for childless heterosexual couples, with this proportion dramatically reducing for other family types (29). A qualitative study exploring communication in IVF (4) found some patients were reluctant to question clinicians or voice concerns, due to a perception that they should be grateful recipients of ‘elective’ treatment.
Let’s not forget it’s elective to do IVF. So it’s not like, you know, you’re still, you’re going through surgical procedures and medication, yet you feel, I…always felt like I couldn’t complain because I was choosing to… do that journey. It wasn’t like you had cancer or a disease or something. (IVF patient, p.2344) (4)
Despite infertility being recognised as a global health issue (30), the perception of IVF as elective appears to have led to acceptance of IVF clinics not facilitating informed decision-making or providing care to meet the needs of individual patients.
The unglamorous topic of patient information
As stated by the then council chair of the British Medical Association in 2021, ‘patient information is fundamental to effective, patient-centred, quality care’ (31). But getting the issue the attention it deserves is a difficult task, particularly in the light of groundbreaking scientific discoveries and exciting new treatments in fertility. However, it does present an area where simple, achievable changes can make a considerable difference.
A new approach
Fundamental to improving patient information is capturing patient voices. As a first step, I propose a comprehensive online survey of fertility patients, focused on the specifics of information provision. In addition to asking respondents to identify information needs and gaps, this would include specific questions regarding whether alternative treatment and medication options have been offered and discussed. As demonstrated above, patients may not realise when they have been given insufficient information to facilitate informed consent.
The survey would be designed in collaboration with Patient and Public Involvement (PPI) partners, with representatives from key organisations (e.g. Fertility Network UK, Fertility Mapper, HFEA, British Fertility Society, RCOG, The Fertility Alliance, and NHS and private IVF clinics) also invited to contribute. Connections would be made with community groups (particularly those involving women from ethnic minority backgrounds), to ensure representation of a diverse range of experiences.
In conjunction with the patient survey, a review of patient information leaflets and IVF clinic websites is needed. A preliminary review indicates information provided is not comprehensive, and in many cases does not include all alternative treatment options. Conducting a full review – informed by survey results and in liaison with PPI representatives (also drawing on Patient Information Forum resources) – would identify gaps in information considered important to patients, as well as examples of good practice amongst NHS and private clinics that could be shared and replicated.
Survey and information review results would be shared with key partners (as listed above) and used to develop a good practice guidance document for IVF clinics. This would enable the review and improvement of patient information provision, including information provided in clinic appointments. This guidance could also be used in the development of new patient information resources, with the recommendation that information is reviewed by PPI representatives prior to publication. More complete information about treatment options – including natural cycle frozen embryo transfer – has the potential to empower patients to seek improvements in their care, holding providers accountable.
Findings would feed into practice, and potentially policy and guidance relating to patient information – tackling misinformation, addressing the vital issue of informed consent, and improving patient experience. This work would help build on positive action currently being taken by organisations in the field, for example the HFEA traffic-light system rating the evidence-base for treatment add-ons, which IVF clinics must link to (12). Fertility Network UK, the British Fertility Society and Fertility Mapper produce useful information guides for current and prospective IVF patients, also working to raise awareness of current issues in IVF. Promisingly, a new charity – The Fertility Alliance – registered in December 2023, has been set up to help those experiencing fertility issues obtain evidence-based, accurate and up-to-date information.
IVF treatments are improving rapidly, with new innovations such as artificial intelligence in embryo selection and human genome editing on the horizon. But as the technology races ahead, it is important to ensure we get the basics right. Ensuring patients receive trustworthy, evidence-based information to enable informed consent is a fundamental issue that cannot be ignored.
References
1. Chawla, S. (2023, May 1). IVF works for the lucky few. After a decade, I finally realised I wasn’t one of them. The Guardian. https://www.theguardian.com/commentisfree/2023/may/01/why-i-quit-ivf-fertility-business-money
2. Royal College of Obstetricians and Gynaecologists (2019). Better for women: Improving the health and wellbeing of girls and women. Royal College of Obstetricians and Gynaecologists. https://www.rcog.org.uk/media/h3smwohw/better-for-women-full-report.pdf
3. Royal College of Obstetricians and Gynaecologists (2019, December 18). Fertility information day to help cut through ‘confusing and contradictory’ advice. https://www.hfea.gov.uk/about-us/news-and-press-releases/2019/fertility-information-day-to-help-cut-through-confusing-and-contradictory-advice/
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28. Lensen, S., Armstrong, S., Vaughan, E., Caughey, L., Peate, M., Farquhar, C., … & Wainwright, E. (2023). “It all depends on why it’s red”: qualitative interviews exploring patient and professional views of a traffic light system for IVF add-ons. Reproduction & Fertility, 4(2), e220136. https://doi.org/10.1530/raf-22-0136
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The Heather Trickey Essay Prize 