On 4 December I took a day off and attended Progress Educational Trust’s one-day conference “Reality Check: A Realistic Look at Assisted Reproduction”. It was a stimulating, thought-provoking discussion on the lack of evidence concerning add-ons in IVF.
The conference explored the many uncomfortable issues of fertility-related practices, technologies and treatments that are the subject of popular claims or widely held assumptions, but that can give rise to challenging questions when examined in light of available evidence.
The conference began with a keynote address ‘What is a fertility doctor’s duty?’ by Professor Søren Ziebe from Denmark who is Head of Fertility at Rigshospitalet‘s Juliane Marie Centre. Professor Ziebe began with a disclaimer to highlight that he heads a publicly funded IVF clinic in a country where free treatments are available, thus, he believed he had no conflicts of interest. He was fairly critical of the IVF industry and some of the ways the HFEA regulates. He demonstrated that whilst ICSI ( Intracytoplasmic sperm injection) is offered at nine out of twelve Danish private clinics, it is not offered at any public clinics. This suggests that the provision of add-ons is financially-driven. This was later addressed again in Professor Christopher Barratt’s lecture, ‘ICSI – Is It Being Overused?’ He concluded that the answer to the question why there is so much ICSI might be actually just IC$$$I.
Other speakers included eminent fertility specialists, mostly from academic institutions. It was a formidable list of speakers dealing with very interesting topics around evidence-based ART and discussed controversial therapies which may be of no benefit to the patients.
Add-ons that don’t benefit patients
Fertility treatment ‘add-ons’ are procedures and treatments offered alongside IVF. The benefits, harms and appropriateness of add-ons are often open to question and the role of add-ons in fertility treatment has become a matter of heated debate among professionals and a source of confusion for patients. Despite this, their use is widespread and regulation of them is minimal. Fertility clinics use add-ons as a way to differentiate themselves in the market.
For example, the most expensive add-on, pre-implantation genetic testing for aneuploidy, PGT-A is sold as a way to screen for chromosomal abnormalities that could lead to failed implantation or miscarriages. Recently, however, a large study found that a single abnormal cell does not doom an embryo and determined that PGT-A had no effect on the rates of live birth. Worse still, those who opted not to transfer embryos and discarded them based on the test’s results may have lost potentially viable embryos. This test might reduce the live birth rate, raising the prospect of desperate patients paying more to worsen their chances.
Another example, steroid treatment for IVF problems also turns out to do more harm than good. In a paper, Corticosteroid therapy in assisted reproduction – immune suppression is a faulty premise, researchers are urging doctors and patients to refrain from using a specific steroid treatment to treat infertility in women unless clinically indicated, because of its links to miscarriage, preterm birth and birth defects.
A recent review of the most commonly used laboratory add-ons is found here: Add-ons in the laboratory: hopeful, but not always helpful. They did not find any high-quality evidence to support their use in routine practice while all the add-ons are presented to patients as ways to increase their chances of a pregnancy.
The recent paper ‘Do à la carte menus serve infertility patients? The ethics and regulation of in vitro fertility add-ons’ discusses how add-ons are regulated and how should they be regulated.
The chair of the British Fertility Society, Dr Jane Stewart talked about the doctor/patient relationship and the need to be honest, open and show integrity. We need more doctors like her. The role of the doctor is not to sell treatments. A considered decision based on medical expertise should be made and sometimes it is appropriate to reject suggested treatment.
Professor Bobbie Farsides’s talk ‘Should Fertility Patients Be Given What They Want, or What They Need?’ was poignant. Given the significant pressures involved, a woman who finds her fertility threatened is increasingly vulnerable and for some women, the desire to be pregnant is so strong that they potentially lose the ability to make a reasoned choice.
Brace yourself for the future IVF industry
While IVF remains an under-regulated field, the global IVF market is anticipated to exhibit significant growth projected to be as great as $40 billion by 2024. The sector will see an increase in entrepreneurship supported by venture capital. With an increasing number of IVF centres being owned by investors rather than physicians, IVF is a highly industrialised part of medical practice. Naturally “industrialisation” leads to “commoditisation.” The pressure to provide returns on investment is expected to increase the pressure to provide add-ons and studies demonstrate that the significant decline in worldwide pregnancy and live birth rates in association with IVF last decade is to do with this trend.
I recommend anyone interested in objective opinion on Add-ons, watch Dr Yacoub Khalaf’s exuberant presentation that took place in Fertility Forum in March 2019.