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Shock! Horror! Or business as usual?

6 June 2016
By Professor Susan Bewley
Professor of Women's Health, King's College London
Appeared in BioNews 854

Recent news stories about unnecessary and expensive fertility treatments both in the UK (see BioNews 852) and a similar outcry in Australia (see BioNews 854) are surprising: not because of their content - a well known open secret within the medical world - but more because of the mystery of what it was that prompted this to become media-worthy now.

IVF normally becomes newsworthy thanks to hype over the latest 'new, improved, breakthrough' assisted reproductive technology (ART). Articles are accompanied by the obligatory picture of a bonnie baby, and frequently berate women for getting it wrong; they are too old, too fat or too stressed to conceive naturally.

As a long-time obstetric ringside observer, it seems to me that unnecessary and expensive treatments are de rigeur, something that's haunted the field for decades. Running a high-risk maternal-fetal medicine service with a tertiary specialist antenatal clinic for many years allowed me to be kept abreast of the latest fashions in spurious diagnoses, misuse of steroids, anticoagulants and immunoglobulins and other dubious interventions. Welcome though the internal debate on the ethics of the billion-dollar baby-making business filling the yawning gap in desired fertility undoubtedly is, still, I am left to wonder - why the sudden angst?

There haven't been any major new findings; we all know that individual cycle success rates are poor but competitively marketed. We know that the joy-filled, constantly rising number of X million babies born via ART is accompanied by an unspoken, larger number of Y million couples disappointed, financially challenged and grieving.

To this figure can be added the pregnancies lost through miscarriage or children damaged through spontaneous and iatrogenic prematurity (especially following multiple embryo transfer or the use of genetically unrelated egg donation leading to pre-eclampsia). So long as the measured aim of the clinic is a pregnancy test or a fetal heart on ultrasound, rather than the birth of a singleton baby at term, then prematurity will continue to constitute the major risk to the health of those children that are born.

For an obstetrician, it was disappointing to see a recent publication from the Centres for Disease Control and Prevention in the USA 'blame' women rather than doctors for multiple pregnancy rates. 'Reducing the number of embryos transferred per ART procedure and increasing use of single embryo transfer […] could help reduce multiple births […] and related adverse consequences. […] Improved patient education and counselling on the maternal and infant health risks of having twins is needed.'

And it was depressing to read a paper, published earlier this year, nearly 40 years into the history of assisted reproduction, reminding Latin American clinics of the basics: 'Given the effect of multiple births and prematurity, it is mandatory to reduce the number of embryos transferred'. Multiple pregnancy and prematurity rates were unacceptably high, the study reported, as would be predicted by a continent using single embryo transfer in only two percent of cycles.

If the reported qualms of 'whistle-blowing' fertility insiders are not due to a particular recent publication, could it be some other worrying signal emerging that's unsettling them? I chaired the UK NICE Fertility Evidence Update Advisory Group (EUAG) in 2015. The group was surprised and almost overwhelmed by the 10,087 research publications published since the 2013 guideline and identified by the search. Vanishingly few were of good quality, or robust enough to consider changing our national guidance – yet many of the inadequately tested techniques are being offered in everyday IVF practice worldwide.

The EUAG noted with concern that it appears that the choice or composition of embryo culture media may affect live birth rates and the growth of children up to two years after birth. For example, a 2014 Cochrane review of 17 randomised controlled trials found that high-dose hyaluronic acid was associated with an increase in live births compared with low-dose or no hyaluronic acid, and multiple pregnancies were significantly higher as well.

Additionally, we drew attention (cautiously, as not yet replicated) to Kleijkers et al's 2014 paper comparing two types of culture medium to assess postnatal growth in the first two years of life. Analyses were adjusted for parental height, weight, smoking habits age, and parity, and infants' gestational age at birth, and gender. At two years of age, children born after culture in one media were 188g heavier and 4.9mm taller than those born after culture in the other.

The emerging worries about possible epigenetic changes related to commercially secret culture media seem to have prompted yet more innovations, like an embryo culture capsule placed in the womb (see BioNews 836). Of course, the adjective 'natural' appears and there is even an extra charge for a device without peer review evidence of safety. Caveat Emptor!

In the global fertility industry, patients effectively pay extra for their putative children to become human experimental subjects. From where I'm sitting, this industry doesn't appear to be bound either by sufficient external regulation to ensure safety, nor the internal self-policing of a traditional profession. And I'm left wondering whether there are more safety features on my kettle than on the children my gynaecology colleagues create.

Declaration of Interests: I was a Member of the NICE Fertility Guideline Development Group and was paid to Chair the NICE Fertility Evidence Update Advisory Group in 2015. I reported the first maternal death in the literature following IVF and have publications on reproductive ageing and obstetric complications. 

16 January 2017 - by Rikita Patel 
A number of IVF clinics in the UK could be misleading people with their advertised success rates, a study suggests...
31 May 2016 - by Sarah Gregory 
The editor-in-chief of Human Reproduction has criticised the overuse of ICSI, following a world report into the use of assisted reproduction technologies...
23 May 2016 - by Lone Hørlyck 
A number of fertility specialists have raised concerns over private clinics offering expensive 'add-on' treatments to patients, sometimes without sufficient evidence of their effectiveness...
26 January 2015 - by Dr Kimberley Bryon-Dodd 
A US study has found that despite increased use of ICSI over recent years, the technique is not associated with any improved reproductive outcomes over conventional IVF...
22 July 2013 - by Dr Archana Vasireddy and Professor Susan Bewley 
The science is clear: most women, even in their late 30's, will succeed in having children, but many will face more infertility, miscarriage and complicated pregnancies...
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