IVF clinics offer expensive 'add on' treatments with limited evidence of their success, new study finds

Picture: Getty Images
Picture: Getty Images 

Australian and New Zealand IVF clinics are offering expensive 'add-ons' despite not having the evidence to prove their effectiveness, new research has found.

Assessing website data from 40 clinics across both countries, researchers at the University of Melbourne found 31 clinics offered a range of 21 different add-ons - non-essential procedures, techniques or medicines, which were sold to parents-to-be as ways to increase the chance of a successful outcome.

Published it the Australian and New Zealand Journal of Obstetrics and Gynaecology (ANZJOG), the study found 90 per cent of clinics did not have any scientific evidence to support these claims on their websites.

Of 10 per cent who did reference publications, these were not found to be 'high quality' evidence. Meaning none of the claims were adequately substantiated either for leading to an increase in success for conception or a live birth. 

Though a few clinics did outline the evidence for their benefits was limited, for most add-ons, the evidence was 'very low quality, conflicting or so imprecise' that it wasn't clear if they were beneficial, harmful or had no effect. 

Among the more popular add-ones were preimplatation genetic testing for aneuploidies, which the study found two in three clinics offered; time-lapse systems, offered by a third of clinics; and assisted hatching, which just over a quarter of clinics advertised. 

Just four clinics were found to be advertising the controversial 'endometrial scratching', the effectiveness of which has been widely questioned. 

The treatments also did not run cheap, some costing up to $3,700. A substantial financial outlay considering the median out-of-pocket cost per IVF cycle in Australia is estimated at $3496, though can often be closer to $5,000-$8,000.

While in NZ, where residents can access two IVF cycles in the public system without charge, the private cost was estimated at NZD $10,000 per cycle.

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Researchers are now calling for all clinics to clearly state that there was no evidence showing their effectiveness. 

"Most IVF add-ons have been introduced into practice without robust evidence of safety and effectiveness," researchers said.

"Although some add-ons are reported to improve outcomes, most of the available evidence is from small, poor-quality studies, the findings of which are often not confirmed by subsequent large trials."

"In addition, IVF add-ons also increase the financial burden for IVF patients, with the cost of some approaching that of an entire IVF cycle."

President of the Fertility Society of Australia and New Zealand, Professor Luk Rombauts, one of the co-authors of the study, said the society had compiled, in conjunction with regulators, guidelines that stipulate how clinics should inform their patients about the pros and cons of add-ons.

Adding patients need to be told as much information as is available on the effectiveness or lack of for each treatment, the cost, potential side effects and known and unknown risks, to provide them with a balanced view. 

However he argued it wasn't always the clinics pushing treatments and that there was considerable consumer demand for certain procedures, likening these to consumers seeking out homeopathic treatments to compliment their fertility treatment. 

"It's remarkable how many women are seeing these or reading about them or they've heard it from friends who have gone through treatment. There is a strong consumer driven request fo these things," he said.

"The market for homeopathic remedies is also unregulated and we know that 20 to 25 per cent of patients will be taking supplements. There's a strong consumer driven component to it, I think the fertility society try to provide clinics with guidelines of how best to inform patients so they can have appropriate informed consent."

He also pointed out the study's limitations in that it relied only on data available on clinic websites.

"The researcher who did all the work was able to get the information on the website, but that doesn't mean if certain clinics aren't providing information on their website, or there's not enough on the website about the effectiveness or risk, that that info wasn't provided. It just isn't on the website, so that's a limitation of the study. It of course may well be provided by the clinicians."

Dr Devora Lieberman, Medical Director, City Fertility Sydney said add-ons needed to be looked at on a case by case basis. 

"I can't speak for all fertility specialists, all I can do is talk about what we do. We are always looking for things that might give our patients that extra edge in terms of achieving a pregnancy, in IVF and fertility, we have a long history of adopting things early on when it looks like there might be a glimmer of hope. We can be pretty quick to jump on the bandwagon if it looks like it helps patients," she said.

"But it's about being honest enough with patients that this is new, we don't have much data and going through the pros and cons, the costs vs. benefits."

Dr Lieberman said as new research came in, clinicians often adapted and what may have been practiced regularly gets shelved if it's proven ineffective.

She said add-ons did have their place, in the right circumstances. Genetic testing of embryos, for example, would not be cost effective for a woman with only one embryo. But for a woman who had experienced multiple miscarriages or a woman over 40 with multiple embryos, it was cost effective if it saved them further unsuccessful attempts.

"If a 40-year-old has six embryos, four of those six may not be normal. But I can't tell that by looking at them. It's extremely cost effective and time effective to pay several thousand to test the embryos, they may not be abnormal, but it may have saved her six months of transfers," Dr Lieberman said.

"I think for some people it's brilliant technology, but you have to be careful who you recommend it to."

Victorian Health Complaints Commissioner Karen Cusack recently recommended fertility operators int he state should get written consent from patients before providing 'add-on' treatments, according to The Age.

The recommendation, one of many, followed an investigation last year into IVF providers in which 121 public submissions on negative IVF experiences were submitted. 

​Add-ons have been a contentious issue in the UK, where authorities implemented a 'traffic light' system in 2017 to provide greater transparency around the procedures. 

Green lights were given to add-ons where more than one randomized clinical trial (RCT) had shown it was effective in improving live birth rates and was deemed safe for patients.

Amber is given to those where there is conflicting evidence over its benefits or patient safety. Red is for those where there is no evidence around its success or safety. 

In 2019, they also ruled that those given red lights could only be undertaken by patients as part of a clinical trial. 

The research follows the launch of the Your IVF Success website earlier this week, which ranks the success rate of Australian clinics to offer greater transparency for prospective parents.