WHEN it comes to making babies, help is at hand. As the age of first-time parents continues to rise, so does the range of fertility treatments on offer – and we aren’t just talking IVF.
There’s a that aims to rejuvenate women’s ovaries by injecting their own blood plasma directly into them. One in Greece claims its similar treatment has reversed the menopause in some women.
Others go even further. Earlier this year, Â鶹´«Ă˝ revealed that a couple had given birth to a healthy boy after undergoing a controversial “three-parent baby” technique by a US clinic in Mexico designed to prevent people passing genetic disorders to their children. In Ukraine, the method is already being used to treat infertility rather than prevent hereditary disease. As private clinics push back the frontiers of reproduction, academics and regulators seem to be struggling to keep up.
Advertisement
“A lot of these treatments haven’t been through clinical trials. We don’t know if they even work”
Given that one in eight couples have fertility problems, and that IVF only works around a third of the time, this rapid progress is welcome. But is it OK to expect people to pay for experimental (though likely safe) treatments? Are clinicians that offer them providing desperate patients with a last stab at parenthood, or offering false hope? And can we hold the industry to a higher standard?
One problem is that a lot of new treatments haven’t undergone clinical trials or even been tried in animals before being offered to people. In other words, we don’t know if they even work. Just last week, a review of the websites of 74 UK-based fertility clinics found that 60 made claims for specific fertility treatments, but only 13 gave evidence to support these claims (BMJ Open, ).
“Very few practices in reproductive medicine are considered established,” says , who coordinates a group on safety and quality in assisted reproduction for the European Society of Human Reproduction and Embryology. “Most are considered innovative or experimental, and haven’t gone through trials.”
Instead, treatments are offered in clinics soon after they are developed. Only later do the clinical trials catch up, either to confirm the benefits of a treatment or find it is useless. “When you work in this field, you see trends,” says D’Angelo. “Things become fashionable, reach a peak and then disappear.”
Take metformin, for example. This diabetes drug, previously linked to longevity, was thought to assist women undergoing IVF treatments, particularly those with polycystic ovaries. As interest picked up, the number of clinics offering the drug increased. It was only years later that trial results came out suggesting that metformin had . Women had been taking the drug, and putting up with its horrible side effects, for no reason.
The latest pricey fertility treatment add-on is time-lapse imaging. This involves placing fertilised embryos under video surveillance while they develop in the lab. In theory, it helps embryologists select the healthiest developing embryo to implant into the uterus.
Except we’re still not really sure what healthy embryos look like, says , scientific director at a fertility clinic in Barcelona and head of a group supporting evidence-based assisted reproduction technology (). “Time-lapse imaging has been talked about a lot, but, as far as I know, there has not been a single prospective randomised trial to support it,” she says.
Untested but OK?
Vassena thinks that treatments should be put through clinical trials before being offered in fertility clinics. This would mean people could only access them as part of a trial – so some would be given a placebo – but no one would have to pay. When people fund their own treatment, the “study” is already been distorted, she says. For example, those that can afford it may already be healthier.
D’Angelo agrees that trials are vital, but doesn’t condemn clinics offering unsupported treatments. “I wouldn’t say it’s wrong,” she says. “Many patients are desperate and would be willing to try treatments that are experimental.”
In fact, most of the embryologists and clinicians contacted by Â鶹´«Ă˝ say they support the use of untested treatments in fertility clinics, provided that they are unlikely to cause harm and that patients are aware that they are experimental and may have no benefit.
“We have to understand that patients are vulnerable, and we can’t exploit that vulnerability,” says , a fertility consultant at Imperial College Healthcare in London. “But just because someone is desperate, doesn’t mean they can’t be informed.”
Things get more complicated when it comes to more controversial techniques, such as that which led to the birth of a baby with, technically, three parents. These have a greater chance of causing harm and need legal oversight, say clinicians.
Treatments involving injecting blood plasma into women’s ovaries, with the aim of reversing the menopause and producing fertile eggs, use a woman’s own blood products. That’s why Hugh Melnick, who has offered ovarian rejuvenation at his clinic in New York, says his treatments are not regulated. Melnick has given these injections to 41 women. “We’ve had no complications,” he says. “The only conclusion I can make so far is that it is safe and has no side effects.”
The concern is that, until long-term trials of experimental treatments take place, it is difficult to know if there are consequences for the embryo, fetus or baby. There are no fool-proof tests for the quality of eggs and embryos, and any problems with a baby’s development may not be evident for years. Most private clinics don’t follow-up their patients in the long term.
Other areas of medicine tend to offer well-trialled interventions, so why does the field of reproductive medicine run on experimental treatments? For a start, the field is young. IVF itself is only a few decades old, and many treatments, such as egg freezing, are much younger.
At the same time, demand is growing. IVF usage has risen in recent years, and as infertility rates increase, this trend will continue. Despite this, assisted reproduction technologies are still not that effective. Labs and clinics around the world are trying to improve the success rates, particularly as private clinics compete to offer the best services to customers.
“Many patients are desperate and would be willing to try treatments that are experimental”
How can we hold the industry to account? Education, says Vassena. When doctors hear about a brand new treatment with a glowing testimonial, they can’t help but want to offer it to their own patients, she says. But they need to be aware of the importance of clinical trials, and to apply for funding to run them.
When it comes to regulation, however, a delicate balance will need to be struck, says Lavery. He believes that tight controls on approving research have slowed down progress in the UK, for example. But at the same time, he thinks that the years of debate by clinicians, ethicists and politicians that led to the UK’s approval of the “three-parent baby” technique was the right one, because of the risks involved.
For now, the best ways to know whether a procedure is backed by evidence is to speak to your doctor, and look for , which analyse all the evidence on a range of treatments and provide easy-to-understand summaries of the results. Even then, though, you are likely to be essentially part of an experiment.
This article appeared in print under the headline “Regulating reproduction”
