Most IVF “add-on” treatments sold to people hoping to boost their chances of having children lack reliable evidence, the largest study of its kind has concluded, leaving patients exposed to false hope, unnecessary medical procedures and significant financial strain.
The comprehensive review, published in The Lancet Obstetrics, Gynaecology & Women’s Health, examined 85 high-quality trials after disqualifying a further 72 on trustworthiness grounds — reflecting mounting concern about the prevalence of suspect or untrustworthy randomised controlled trials within reproductive medicine. Researchers from the University of Melbourne found that for seven of the ten most common add-ons, there was either no effect on fertility or the results were inconclusive due to limited or poor-quality data.
“In many countries, infertility care is largely provided by private clinics where IVF is highly commercialised, and some add-ons are extremely expensive,” said Dr Sarah Lensen of the University of Melbourne. “Our review finds a lack of evidence that most of the IVF add-ons we assessed provide any benefit to patients.”
The seven treatments found to have no proven benefit or inconclusive evidence are: acupuncture, corticosteroids, endometrial receptivity testing, intralipid infusion, intraovarian injection of platelet-rich plasma, intrauterine infusion of platelet-rich plasma, and pre-implantation genetic testing for aneuploidy (PGT-A). Despite their widespread availability, the review could not identify robust data showing they improve live birth rates.
Only three add-ons showed even weak evidence of possible benefit. EmbryoGlue — an embryo transfer medium containing hyaluronic acid — may increase the probability of pregnancy and live birth, but the effect on live birth rates was not robust. Endometrial scratching, a minor procedure to disturb the uterine lining, may also increase the probability of pregnancy and live birth, though again the evidence is considered weak. Physiological intracytoplasmic sperm injection (PICSI), a sperm selection technique, has weak evidence suggesting it may lower the risk of miscarriage.
The research underscores the scale of the problem. More than 70% of IVF patients in the UK, Australia and New Zealand pay for one or more add-ons during treatment. A UK patient survey found 67% of respondents had used at least one add-on, with time-lapse imaging, EmbryoGlue and endometrial scratching the most common. Another survey found 77% of Australian IVF clinic websites made unsubstantiated claims about add-ons. In the UK, 81% of add-ons were offered by clinicians, with only 19% requested by patients themselves — a dynamic that experts say leads patients to perceive availability as an implicit endorsement of benefit.
The financial burden is substantial. In the UK, the average cost of add-ons for self-funded cycles was £1,708, on top of fertility testing averaging £1,015 and other expenses of £3,217. Privately funded treatment per cycle ranges from £5,000 to £13,000, with an average of £11,950; some clinics charge up to £20,000 once all additional costs are included.
Misinformation is rife, according to Dr Lensen. “There is widespread misinformation about IVF add-ons with private clinic websites and patient forums on social media — major information sources for patients — often overstating the benefits and omitting the costs and risks of add-ons,” she said. Patients primarily rely on search engines, fertility clinic websites and the Human Fertilisation and Embryology Authority (HFEA) website for information.
Regulatory bodies have taken note. The HFEA provides a rating system for add-ons (formerly traffic lights, now five categories), but none have yet received a “green light” indicating sufficient evidence of effectiveness for most patients. The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending against several popular add-ons due to lack of clear evidence. Separately, the Competition and Markets Authority (CMA) has issued guidance emphasising that fertility clinics must not mislead patients and must supply all relevant material information to enable informed decisions.
Experts are calling for better safeguards. “IVF clinics and clinicians should carefully consider whether it is appropriate to offer unproven add-ons, as their availability is often perceived by patients as implicit endorsement of benefit,” Dr Lensen said. The review’s authors stressed that unproven add-ons lead to false hope, greater financial strain and needless medical procedures at what is already an intensely difficult time for patients.
