Most in-vitro fertilisation (IVF) “add-ons” or “optional extras” don’t work or lack evidence when it comes to increasing the chances of a live birth, according to a new University of Melbourne-led study.
In the study published in The Lancet Obstetrics, Gynaecology, & Women’s Health on Wednesday, researchers analysed 10 popular add-on therapies frequently offered by IVF clinics, including acupuncture and corticosteroids, to determine whether they increase the chance of pregnancy and live birth, as well as risk of miscarriage.
Despite the lack of robust evidence, the vast majority of women undergoing IVF pay for add-ons, which can add thousands of dollars onto the final bill. A 2021 study found 82 per cent of Australians had used at least one when trying to have a child.
These therapies are often marketed as addressing common problems that can arise during IVF, like increasing the quality of sperm and eggs, the number of eggs retrieved or fertilisation rates.
The meta-review of 85 trials found weak evidence for some possible benefit from three IVF add-ons: EmbryoGlue (embryo transfer media containing hyaluronic acid), endometrial scratching (collecting a biopsy sample of a person’s endometrium) and physiological intracytoplasmic sperm injection (a specialised form of IVF used for the treatment of severe cases of male-factor infertility, involving the injection of a single sperm directly into a mature egg).
Researchers found no effect on fertility or inconclusive results due to limited or low-quality data for the remaining add-ons.
Health professional Hilary Smith, 44, underwent IVF at a clinic in Melbourne. She and her husband were successful on the first round, and now have a five-year-old daughter.
While Smith, who now lives with her family in Brisbane, admits she was “really lucky”, she also says she felt pressured by clinic staff to pay for EmbryoGlue, endometrial scratching and pre-implantation genetic testing.
Smith says these were pitched as “necessary” therapies at a vulnerable time, without discussion of the potential harms – such as the high risk of false positives that pre-implantation genetic testing carries – and available evidence.
“You are putting your trust in these professionals to help you achieve a thing you haven’t been able to achieve on your own, that you dearly wish and long for,” she says, adding, “the extent to which you feel your feelings on a day-to-day basis is much, much greater when you’re on the IVF treatment hormones. That just makes you much more vulnerable to not feeling like you know what to do or whom to trust or where to go.
“It does mean that you just sort of say, ‘Yes, OK, whatever it takes’.”
Smith contributed her experiences to the paper and is credited as a lived experience researcher.
Dr Sarah Lenson, lead author from the University of Melbourne’s Department of Obstetrics, Gynaecology and Newborn Health, hopes the findings will help IVF patients make more informed decisions. “We want patients to know these things are optional and to have access to information about whether there’s evidence to inform their own decisions.”
The research adds to mounting evidence and warnings from industry experts about the efficacy of these therapies.
An analysis of non-core services being offered to Australian fertility patients last year, compiled by researchers from three universities, warned the rampant use and marketing of IVF add-on services with little to no scientific evidence is falling through the cracks of our fertility regulation.
The warning came after Australia’s health ministers called for a review into the country’s assisted reproductive sector following a series of bungles and scandals.
Dr Petra Wale, president of the Fertility Society of Australia and New Zealand (FSANZ), says the paper “will help fertility specialists find or identify where there is or isn’t clinical evidence for their practice”.
However, Wale says the findings fit in with existing NHMRC ethical guidelines on the use of assisted reproductive technology, which she believes are largely being followed by Australian clinics.
FSANZ supports the review, including its recommendations for a national regulatory approach, as opposed to the current state-based regulatory system, and greater independent resources.
“Part of our 10-year fertility road map that we’re calling for is for the government to get into the fertility education space,” says Wale.
Lenson and her colleagues have also published a second paper alongside the meta-review, which expands on The University of Melbourne’s evidence-based IVF website.
“That is our solution to the problem – to have this resource that patients can trust, that’s produced by independent researchers and that we update continually,” she says.
The second paper found “more than 60 per cent of patients are using social media for information about IVF and IVF options, and we know when we look at the content on social media, that the accuracy and quality is very variable,” says Lenson.
Dr Karin Hammarberg, adjunct senior research fellow at Monash University’s School of Public Health and Preventive Medicine, who was not involved in the study, praises the review for its “methodological rigor” by collating a large volume of data.
“To get a really good grip on if something has merit or not, you really need big numbers because the difference that [an add-on] would make is always going to be a small difference. You have to actually have big numbers to show it in a credible way.”
She says the focus on birth rate, rather than chance of pregnancy, is also important.
“If you look at [IVF] clinic websites, they notoriously talk about pregnancy rates because they’re always higher than live birth rates, simply because a lot of pregnancies are lost,” she says.
Both Lenson and Hammarberg support calls for stricter regulation around Australia’s reproductive assisted technology sector, including when it comes to add-on services.
“The money that people spend on this can really be significant,” says Hammarberg.
“If you have enough of these add-ons that really have very doubtful benefits, you might deny yourself the opportunity to have one more cycle because of the cost, and one more cycle will always give you more chance.”
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