This new rule will ensure that patients seeking fertility treatment are fully informed before undertaking any extra procedures that have not been proven effective.
'Clinics tell us it's due to patient pressure,' said Sally Cheshire, chair of the HFEA. 'We're saying clinics need to be robust and ethical in what they offer, particularly if they're asking patients to pay for those treatments.'
'Add-ons' are optional procedures which aim to increase the chances of a successful pregnancy resulting from fertility treatment. Currently, 70 percent of fertility clinics in London offer add-ons, and the price for a single procedure can range from £400-£1000, according to Tech Times. However, the most commonly offered add-on treatments have either never been tested in clinical trials, or have not been tested thoroughly enough to demonstrate efficacy, according to the HFEA.
Add-ons such as 'assisted hatching', which uses a laser, acid or other means to break through an embryo's protein coating to assist implantation, or 'time-lapse imaging', which tracks the development of embryos under a microscope, have not been proven to increase live birth rates. Similarly, 'reproductive immunology', which uses drugs to suppress the mother's immune system, not only lacks evidence demonstrating efficacy, but has been shown to be associated with harmful side-effects such as chronic infections, blood poisoning and severe allergic reactions.
Two common add-ons, endometrial scratching and the 'Augment' treatment which injects more of the mother's own mitochondria into her eggs, have recently been shown to have no effect in clinical trials (see BioNews 957 here and here).
'There isn't anything particularly different as far as we're concerned,' said Cheshire. 'There's no effective evidence that these treatments work, and some of them may even be potentially harmful for some patients, which clearly isn't ethical.'
This new rule for add-ons is set to come into effect in October according to The Guardian, pending approval from the Health Secretary.