Sat, 20 May 2023 at 10:00 am BST
Growing numbers of people are buying at-home fertility tests despite concern from some leading doctors that these products may cause already anxious would-be parents to worry unnecessarily about their ability to have children.
They also say there is an urgent need for better regulation in this area.
There has been a tripling in sales of Superdrug’s at-home hormone tests since December last year. The health and beauty retailer also offers consultations with online doctors about testing, with average weekly bookings rising by more than 400% during the same time period. Meanwhile, the health company Randox has reported “considerable growth” in its fertility testing kits.
Most companies offer the testing of the anti-Müllerian hormone (AMH), which can help estimate the number of follicles inside the ovaries, and progesterone, a hormone that plays an important role in the menstrual cycle.
Fertility is big business
It comes amid big waiting times for help on the NHS after the Covid pandemic effectively shut down a range of non-essential services. Several hundred thousand women are on a waiting list to see a gynaecologist on the NHS, with the average waiting time doubling from 6.9 weeks pre-Covid to more than 14 weeks.
Fertility is big business. This weekend (20-21 May), London’s Olympia plays host to the Fertility Show Live, an event where would-be parents can talk to fertility experts, attend seminars and check out the latest products.
At-home fertility tests vary in price. For example, Superdrug offers a range of products including an AMH blood test kit costing £76.99, a progesterone test kit costing £39.99 and a combo test pack for £97.99. An at-home hormone and fertility test kit from the specialist firm Hertility is £149.
However, some experts have expressed concern that while the test kits sold by retailers have benefits because they can be done cheaply at home, they also need to be used with care. Doctors say that if the test is not done alongside expert knowledge and guidance, it can cause unnecessary worry and stress for consumers.
There is some regulation of at-home tests. The Medicines and Healthcare products Regulatory Agency does not approve medical devices, including testing kits, although manufacturers have to register the kits with it, and it is understood the regulator assesses them for accuracy. However, there is no oversight of the medical advice or healthcare implications of the service. The fertility regulator, the Human Fertilisation and Embryology Authority (HFEA), says home testing kits do not currently fall within its regulatory remit.
Dr Ippokratis Sarris, the director and consultant in reproductive medicine at King’s Fertility, says there has been growth in technology designed specifically around women’s health, but that it raises “scientific and ethical issues”. He adds that any startup in this area should look at this from the outset because they are working with “vulnerable” people, and there is a risk of “exploitative practices”.
He says medicine in general “is moving away from the traditional model of a ‘doctor-patient’ relationship … Femtech is allowing a ‘direct to consumer’ approach, where any individual can access themselves whatever test they think suits them after they ‘self-diagnose’ a problem or want an ‘answer to a question’. As femtech products start giving people the ability to bypass healthcare professionals and take control of their own health in a way that was not previously possible, new regulations may indeed be required to deal with new issues, and femtech companies need to be accepting of these new rules.”
He says the positives of at-home testing are that it is affordable and easy to do at home. However, Sarris says services need to be regulated, adding that a lot of tests do not take someone’s clinical history into account and that without context, results can be hard to understand. He says tests should be looked at in the context of treating something specific rather than just as a blanket diagnostic or screening method.
“For example, a blood test looking at ovarian reserve has limited predictive values if someone is not trying to conceive,” he says, adding that these tests can be hard to interpret, meaning they cause “unnecessary worry for people”.
Dr Channa Jayasena, the head of andrology at Imperial College London, says that in some ways, getting tests done in this way can save time and money but the key question is making sure people are aware of what tests they actually need to do. “If someone is anxious, they can overcheck these things and potentially waste a lot of money.”
Jayasena adds that hormone levels are always changing, and some tests won’t be effective unless done at the correct time of day or menstrual cycle, but that people do not know this, and companies do not always advertise it. “That is wrong,” he says.
“Some people will spend lots of money on tests, and some of these tests are actually not used by medical professionals because they are useless. We get people coming in with spreadsheets of immense amounts of data that they have collected that is actually quite meaningless,” he adds. Jayasena claims there are very few times when people “really need these tests”.
“If you have fertility problems, you probably need to see someone who knows your history and what to test. I don’t know how to service cars, for example, but I could have a go. When testing fertility, it’s a bit like that – having the tools to look at a car’s engine but with no expertise. People need someone to guide them or there is a chance of getting tangled up.”
Rachel Cutting, the director of compliance and information at the HFEA, says people with fertility problems should speak to their GP.
“There are home testing fertility kits that can help people to understand more about their fertility. This can include testing for hormones for women and analysing the sperm sample for men. These tests can give some indication of how fertile you may be but the results are not guaranteed, so this needs to be taken into account,” she says.
Women don’t want to have to jump through hoops or pay through the nose to better understand their bodies
Hertility co-founder Helen O’Neill
Meanwhile, Sarah Norcross, the director of the charity Progress Educational Trust, believes it is “concerning” that women are increasingly self-testing rather than consulting their GP. “This indicates there is a failure in addressing the issues women face when it comes to their reproductive health,” she says.
However, Helen O’Neill, a lecturer in reproductive and molecular genetics and a co-founder of the self-testing company Hertility, says that long NHS waiting times mean “people have decided to take matters into their own hands instead of waiting for GP referrals”.
She adds: “Women don’t want to have to jump through hoops, wait for long periods of time to be seen or pay through the nose to better understand their bodies and take action if there’s anything that needs to be addressed.”
She says that is why she started Hertility, adding that it “never tests hormones in isolation … We interpret them while taking into account your age, medical history (including pre-existing conditions), menstrual cycle patterns, lifestyle habits such as smoking, drinking, etc, all of which are known to impact hormone levels and fertility”.
O’Neill says that not all conditions can be diagnosed by a blood test alone. She adds: “Our blood test will be able to pick up on hormonal imbalances and, combining this with your answers to our online health assessment, our clinicians would then recommend suitable next steps and further investigation, such as an ultrasound scan, repeat blood test or doctor’s consultation.”
Superdrug told us that it offers “a range of fertility and health tests alongside doctor advice, which are widely offered in fertility clinics and GP surgeries, in order to provide insight, choice and support for people”.
It added: “As part of our at-home fertility tests on offer, people have access to professional advice and support from our team of doctors to discuss their results in greater detail, enabling them to have a more informed understanding of their fertility.”