A year has passed since the Human Fertilisation and Embryology Authority (HFEA) announced its investigation in May 2017 into the efficacy of ‘add-on’ treatments at UK fertility clinics. This followed widespread media coverage questioning the benefits and marketing to patients of costly ‘add-on’ treatments.
What are ‘add-ons’?
‘Add-ons’ are optional ‘paid for’ extras over and above standard fertility treatment, such as IVF. According to the HFEA, they are “typically emerging techniques that may have shown some promising results in initial studies but haven’t necessarily been proven to improve pregnancy or birth rates”. Some UK fertility clinics include certain ‘add-ons’ in their treatment packages whilst others cost extra.
Fertility patients must decide whether to invest in ‘add-ons’ whilst undergoing treatment, which can add thousands of pounds to their bill. Fertility patients can be susceptible to the lure of expensive ‘add-on’ treatments in the hope this will increase their chances of a successful pregnancy and birth. At the same time, it can be difficult for patients to decipher the myriad of information and work out which ‘add-ons’ are beneficial and worth the investment. This has lead to criticism that patients can be misinformed and prone to spending excessive amounts on unnecessary fertility treatment.
The HFEA’s response
Against this backdrop, the HFEA published its latest business plan on 21 May 2018, including its strategic vision of high quality care for everyone affected by fertility treatment. In that report it explained its strategy up to 2020 will focus on “high quality, safe care” and “effective evidence-based treatment and treatment add-ons that are well explained”. It went on to say:
“We carried out additional inspections at a number of clinics after a Daily Mail investigation alleged poor practices in a number of clinics. We also began a conversation with the sector about clinic leadership, with the aim of putting in place new incentives to encourage and support excellent clinic leadership.”
Following its investigation and commitment to improving information to help patients understand their options, the HFEA has just published a new traffic light system for ‘add-on’ treatments. This new system provides colour coded information about ‘add-on’ treatments.
A treatment is marked red if there is no evidence to show that it is effective and safe. A yellow symbol indicates there is a growing body of evidence showing promising results but further research is still required. A treatment is designated green where there is more than one good quality study which shows that the procedure is safe and effective.
The HFEA will review and update this information annually. From this autumn, the HFEA will also require UK fertility clinics to provide evidence-based information to patients about ‘add-on’ treatments.
Which ‘add-ons’ have a ‘red’ rating?
The HFEA traffic light system has designated assisted hatching as ‘red’, meaning there is no evidence that it is an effective procedure. Before an embryo implants in the womb, it must break through or ‘hatch’ from its thick layer of proteins called zona pellucida. In assisted hatching, acid or a laser is used to break through the zona pellucida to help the embryo hatch. The HFEA states:
“The National Institute for Clinical Excellence (NICE) is the national body advising doctors on treatments. It says:
“Assisted hatching is not recommended because it has not been shown to improve pregnancy rates.”
NICE also says that further research is needed to find out whether assisted hatching has an effect on birth rates and to examine the consequences for children born as a result of this procedure.
Some clinics believe assisted hatching can lead to higher birth rates in very select cases. For example, it has been noted that the zona pellucida may be thicker in some older women, so weakening or thinning it may help the embryos hatch, but this hasn’t been proven.”
The HFEA has also given a ‘red’ rating to intrauterine culture, reproductive immunology tests and treatment and some PGS procedures.
Which ‘add-ons’ have an ‘amber’ rating?
"The HFEA reports that there are some promising early results, although more evidence is needed, about elective freezing of all embryos created through IVF or ICSI. The embryos are then thawed a few months later and transferred to the woman during a frozen embryo transfer cycle. The HFEA states:
“There is some evidence that the body’s hormonal response to fertility drugs can affect the lining of the womb, which makes it more difficult for the embryos to implant. Freezing the embryos means they can be transferred back into the woman when the womb lining is well developed.
It’s also thought by having all their embryos frozen, women are at lower risk of suffering from ovarian hyperstimulation syndrome (OHSS), an overreaction to fertility drugs. This is because OHSS is more common and more severe when it occurs during a pregnancy.”
The HFEA has also allocated ‘amber’ ratings to artificial egg activation, embryo glue, endometrial scratching, some PGS techniques and time-lapse imaging of embryos.
The value of specialist fertility law advice
Fertility patients need to give informed consent to treatment at UK fertility clinics. This requires an understanding of both the medical and legal issues and options in equal measure in each case.
Fertility treatment and assisted conception create complex legal issues. Patients are required to sign a range of consent forms dealing with their legal status, rights and responsibilities for their eggs, sperm and embryos and future families and children. To make informed decisions, patients need specialist tailored fertility and family law advice to understand the issues, implications and outcomes for themselves and their families in the short, medium and longer term. These important and complex legal issues should not be left in the hands of medics and nurses who are medically and not legally trained. Specialist fertility and family law advice should not be overlooked or viewed as an ‘add-on’.
If you would like advice on how UK fertility and family law affects you contact Louisa Ghevaert, Head of Fertility and Surrogacy – Director Family Law at Vardags, by email [email protected] or call 020 7788 6615.