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Treatment add-ons

Your clinic may offer you treatments in addition to your routine treatment, with a claim that they will improve your chances of having a baby. These are often called treatment add-ons. For some treatment add-ons, there is not enough evidence to show that they are safe and/or effective at increasing your chances of having a baby. This page explains what some of these treatment add-ons are. For more detailed information, you should contact your clinic to discuss this further with a specialist.

What are treatment add-ons?

Treatment add-ons are optional additional treatments that you may be offered on top of your routine fertility treatment, often at an additional cost. Some clinics may refer to treatments add-ons as ‘supplementary’ or ‘embryology treatments’. There are a wide range of treatment add-ons on offer including tests, drugs, equipment, holistic or alternative therapies, and surgical interventions.

However, all treatment add-ons share one common characteristic: they claim to improve the chances of having a baby (live birth rate). Evidence on whether some treatment add-ons are safe or effective is often missing or absent. These claims can attract a lot of attention with many patients opting for a treatment add-on thinking that it may be the best option for them despite there being little or no evidence to prove it is.

Treatment add-ons have varying levels of scientific evidence to support their effectiveness and safety and, at times, this evidence can be contradictory. It is important to keep in mind that for most patients, routine fertility treatment is an effective option on its own.

We aim to publish clear and reliable information about some of the treatment add-ons that lack sufficient evidence to show that they are effective and/or safe. This allows patients to make an informed decision about whether using a treatment add-on as part of their treatment is the best option for them.

To make it easier to understand the scientific evidence for each treatment add-on we have developed the HFEA’s traffic-light rated list of add-ons. The treatment add-ons included on this page are not a complete list and additional relevant treatment add-ons will be included over time.

What do the traffic light ratings mean?

The traffic light rating system consists of three colours that indicate whether the evidence, in the form of high-quality randomised control trials (RCTs), shows that a treatment add-on can safely improve the live birth rate for someone undergoing fertility treatment. You can read more about RCTs further down this page.

It may be true that some add-ons show benefits in certain groups of patients. Where relevant we have outlined this in the description of that add-on. Your clinic will also be able to discuss with you whether a treatment add-on would be appropriate given your personal circumstances.

green traffic light

We give a green symbol for an add-on where there is more than one good quality RCT which shows that the procedure is effective at improving live birth rates and is shown to be safe for patients to use. These treatment add-ons may be routinely used in fertility treatments therefore will not be included in this review list.

amber traffic light

We give an amber symbol for an add-on where there is conflicting evidence to show that an add-on can improve live birth rates, or that the add-on is safe for patients to use. This means that the evidence is not conclusive and further research is required, and the add-on should not be recommended for routine use.

red traffic light

Red - We give a red symbol for an add-on where there is no evidence to show that it can improve live birth rates. We also give a red symbol for an add-on where there is evidence to show that the add-on is unsafe.

The January 2019 consensus statement between the HFEA and 10 other professional and patient bodies agreed that treatments that have no robust evidence of their safety and/or effectiveness should only be offered in a research setting. Patients should not be charged extra to take part in research, including clinical trials, and should not be charged to use red-rated treatment add-ons if the reason for its use is to improve live birth rates.

For specific patient groups there may be reasons for the use of a treatment add-on other than to increase live birth rate, for example to reduce your chances of having a miscarriage. In these situations it may be appropriate for you to be offered a treatment add-on as part of your treatment and not in a research setting.

How are traffic light ratings decided?

The HFEA’s Scientific and Clinical Advances Advisory Committee (SCAAC) is a subcommittee of the Authority. Every 12 months SCAAC reviews the available research for each treatment add-on included in the HFEA’s traffic-light rated list of add-ons to determine whether there is new evidence that the add-on safely improves live birth rates. This review process is informed by advice from an independent expert in systematic reviews. SCAAC then determines an appropriate traffic light rating for each treatment add-on based on this evidence. The minutes of this decision-making process, and the specific evidence used to inform these decisions, can be found in the description for each treatment add-on.

The best way to be confident that a treatment add-on is safe and effective enough to be used routinely is to look at its use within the setting of an RCT. The traffic light rating for each treatment add-on is based on our review of RCT evidence.

In an RCT, patients are assigned randomly to two groups: a treatment group, given the new treatment, and a control group, given either a well-tried treatment or a placebo. The number of patients included is very important, with more patients giving more accurate results. Ideally, several different groups of researchers or scientists should have performed high-quality RCTs and follow-up studies to be sure a new treatment is effective and safe.

It may be the case that there is evidence from other studies which are not RCTs that suggests some benefit for the use of an add-on, either to increase live birth rates or other outcomes such as a reduced rate of miscarriage. This may include cross sectional studies, case-control studies or cohort studies. These studies use less rigorous approaches to investigate the effectiveness and safety of treatments, so the results are less reliable than RCTs. We consider this evidence to be poor quality and it is not considered by SCAAC in the traffic light assessment of a treatment add-on. Your clinic should provide you with the evidence of effectiveness of any treatment they offer you.

Treatment add-ons

How are treatment add-ons introduced to this list?

If you feel that there is a treatment that should be included on the HFEA’s traffic-light rated list of add-ons due to a lack of evidence supporting its use for increasing live birth rate, then you are able to make an application to the HFEA. We will use this application form, and any supporting evidence submitted with it, to determine whether the treatment is suitable to be part of the HFEA’s traffic-light rated list of add-ons. The HFEA will consider the following questions:

  • whether the treatment is an additional, non-essential treatment
  • if patients undergoing fertility treatment are currently being offered, or requesting, the treatment on a regular basis and/or are being charged for its use in their treatment;
  • whether the safety of the procedure, for both patients and children born as a result of treatment, cannot be demonstrated;
  • the likelihood that treatment doesn’t produce the desired outcome compared to using established fertility techniques without the treatment; and
  • whether there is a lack of standardised procedure between different laboratories and the lack of potential for this treatment to be implemented by other centres.

Find out more about the application process

What other work is the HFEA doing around treatment add-ons?

The HFEA has been concerned about the fair and safe use of treatment add-ons for some time. We are keen to work with patients, clinics, researchers and professional and patient groups to bring about a culture change towards more responsible innovation. We are undertaking numerous pieces of work that involve treatment add-ons with an aim to:

  • raise awareness of treatment add-ons and the issues therein
  • encourage responsible supply and only to be used when a treatment add-on is indicated
  • prevent patients from being misled by ensuring, through inspections and our own published information, that patients are provided with information that is clear and reliable
  • ensure informed consent is obtained
  • enhance patient safety by investigating how outcomes and follow ups can be best assessed
  • encourage research to assess whether any current or future add-ons increase success rates
  • require clinics to provide costed/itemised treatment plans where the costs of treatments and add-ons are clear and to avoid costs being lost in package prices
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Review date: 12 October 2022

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