Add ons – do they add up?

I gave a talk at The Fertility Show on Saturday about add ons, and promised to put my notes on the blog, so these are some of the key points, and links to useful sources of information.

What are add-ons?

  • They are additional treatments which your clinic may offer on top of IVF/ICSI
  • They are new or emerging treatments and there may be limited evidence about how effective they are
  • Some may have shown some promising results in initial studies but may not be proven to improve pregnancy or birth rates
  • Some clinics offer lots of add ons and may give you what looks like a shopping list of additional treatments to choose from. Some don’t offer them. This isn’t an indication of how good or forward-thinking a clinic is – some fertility experts may not be convinced that some add ons are worthwhile or safe.
  • Some clinics charge for add ons, others may include particular add ons in the cost of treatment because they think they make a difference and believe they should be part of IVF.
  • Add ons can be expensive and may substantially increase what you pay for your IVF

The Human Fertilisation and Embryology Authority (HFEA) has a list of some of the more common add ons you may be offered on their website, and a grading system for them

They include:

  • Assisted hatching
  • Artificial egg activation
  • Elective freeze-all cycles
  • Embryo glue
  • Endometrial scratch
  • Intrauterine culture
  • Pre-implantation genetic screening (PGS)
  • Reproductive Immunology
  • Time-lapse imaging

It can be difficult to know what to think about these new treatments, and the HFEA carried out patient survey to try to find out what people thought. The views ranged from those who were very strongly in favour of add ons to those who felt patients should not be offered treatments that we don’t know work. The overwhelming feeling from patients was that they didn’t want to miss out on something which might make a difference, but that this had to be balanced by the need to protect their interests.

Assessing the evidence is key and you want to know is:

  • What evidence there is about how effective something is
  • What evidence there is about whether it is safe
  • Does it carry any risks
  • How much does it cost

How do you assess the evidence?

As lay people, when we hear about evidence we may give any research or scientific paper equal weight, but in fact evidence isn’t quite as black and white as we may think.

 

The best scientific evidence comes from randomised controlled trials. In these trials, people will be divided into those who have the new technique or treatment and those who don’t in a randomised way. It is important when assessing evidence to look at whether the study included all patients or just a specific group. Sometimes research may have a narrow age range, or may have only looked at people with one specific type of fertility problem.

You should also look at the number of people included in the study. The most meaningful research will have involved a large group but sometimes you may discover that studies have taken place in one specific clinic and may involve tiny numbers of people.

Finally, check the outcomes. You want to look at studies where a healthy live birth is the outcome but some studies may stop at a fertilised egg or positive pregnancy test and this may not translate into an increase in births.

How the HFEA can help

The HFEA got together a group of leading scientists and fertility experts to look at all the existing research on each of the add ons, to assess it and to develop a traffic light system for add ons.

There is a green symbol where there is more than one good quality study which shows that the procedure is effective and safe.

A yellow symbol where there is a some evidence or some promising results but where further research is still required.

And a red symbol where there is no evidence to show something works or that it is safe

The decisions made by the group were then re-assessed by an expert in evidence to ensure every traffic light had been correctly assigned.

Green lights

Not one of the add ons mentioned at the start was given a green light to say that there is “more than one good quality study which shows that the procedure is effective and safe”

Red lights

There are a few red lights which means there is currently no evidence for assisted hatching, intrauterine culture, PGS on day three and reproductive Immunology. There may also be risks here too so do read the evidence carefully on the HFEA’s information page.

Amber lights

A lot of the add ons fall into amber where more evidence is needed. This includes endometrial scratch, freeze all cycles, egg activation, embryo glue, PGS on day five or six and time lapse.

For two of the add ons in this category, freeze-all cycles and endometrial scratch, there are big multi-centre trials going on at present in clinics across the United Kingdom. If you want one of these add ons, ask your clinic if they are taking part in the trial as you could end up getting the add on itself free of charge (this doesn’t cover the cost of the IVF/ICSI and you may be randomised into the other part of the trial and not get the add on, but it may be a good way forward if can’t afford to pay for the add on)

The cost of add ons

Some clinics offer add ons such as embryo glue or time lapse as part of a treatment cycle to every patient they treat. Others charge, and prices can vary hugely. There is often no discernible reason for wide discrepancies in price, so do look into this by finding out what a number of different clinics are charging for any add on you are considering.

Key questions

If your clinic offers you an add on, make sure you ask some questions first:

  • Why are you offering me this treatment?
  • What evidence is there that it works?
  • What increase in success have you seen with patients similar to me?
  • What are you charging and how does it compare to other clinics?
  • If you are charging more, why is this?

There are also some questions to ask yourself:

  • Are you happy with the evidence your clinic has given you?
  • Have you read the information on the HFEA website?
  • Can you afford to pay for it?
  • If you pay for it, would it affect your chances of being able to pay for another cycle if it doesn’t work?

Whatever you decide,make sure you are as fully informed as you can be about your treatment, and make sure you have read through all the evidence on the HFEA website which is there to help you to make an informed decision about your treatment.

Your views needed!

If you are having fertility treatment, or have done recently, you may have been offered some additional extras on top of your IVF or ICSI. These additional treatments include things like time-lapse imaging, embryo glue, endometrial scratching or reproductive immunology. Not all clinics offer every type of additional treatment. Some may not suggest them at all, others include them in the price of IVF or you may be given the option to pay for add ons if you would like them.

Fertility Network UK, the patient charity, and the fertility regulator the Human Fertilisation and Embryology Authority, or HFEA, is interested in finding out more about what you think about these add ons, how they should be offered and what you need in order to make decisions about whether to pay for them. Most of these add ons are not fully proven to increase your chance of getting pregnant.

If you have had treatment recently or are going through treatment currently, do take a minute to answer the short questionnaire to help them find out more about what your views are on this subject. You can find the link by clicking here

 

Expert opinion on treatment add-ons

If you’ve been unsure who to believe about fertility proline_level_measurement_in_eurasian_national_universitytreatment add-ons, you may be interested in some impartial and expert advice in two new scientific opinion papers published by the Royal College of Obstetricians and Gynaecologists (RCOG). They call for more high quality research into the role of natural killer cells in fertility and the effect of endometrial scratching on pregnancy outcomes.

Scientific Impact Papers (SIP), are up-to-date reviews of emerging or controversial scientific issues. The first paper looks at the role of uterine natural killer (uNK) cells, how they are measured, the role of testing and the evidence behind any links to improving implantation rates and early placental development. The paper clarifies that uNK cells are completely different from peripheral blood natural killer cells (which you would be testing in the blood tests some fertility clinics currently offer).

The paper makes it clear that there is no evidence to offer routine tests for NK cells as part of fertility treatment or testing, and that there is uncertainty about how NK cells are measured and reported. The paper says that treatment for raised levels with intravenous immunoglobulin (IVIg)  is not supported by the current evidence and, since it may have serious adverse effects, should not be used..

The second opinion paper explores the effect of endometrial scratch on pregnancy outcomes in women who have experienced recurrent miscarriage and recurrent implantation failure.

Endometrial scratch is a procedure which is hypothesised to help embryos implant more successfully after IVF/ICSI and involves scratching the lining of the womb.

Several studies have examined the impact of endometrial scratch in the cycle preceding an IVF treatment cycle in women with recurrent implantation failure, which appear to provide convincing evidence of benefit of superficial endometrial scratch in improving the implantation rate in this group of women. However, the effect of this treatment on pregnancy outcomes in women who have experienced recurrent miscarriage or those undergoing their first IVF cycle is uncertain.

Professor Adam Balen, Chair of the British Fertility Society (BFS) and spokesperson for the RCOG, said: “These two papers look at the current available evidence which exists and give much-needed guidance to both healthcare professionals and the public on these two topics. It is important that patients receive full information about treatments, the current evidence for benefit and whether there are any side effects or risks associated with it.”

Mr Mostafa Metwally, Vice Chair of the RCOG’s Scientific Advisory Committee added: “There is currently no convincing evidence that uterine natural killer cells are the cause of reproductive failure. Despite this, a number of women are requesting and being offered analysis of either peripheral blood or uterine killer cells and the value of these measurements remains controversial. Current evidence suggests that endometrial scratch may benefit women with recurrent implantation failure and therefore defining the optimal number of previously failed embryo transfer cycles needs to be evaluated in large cohort randomised prospective clinical trials.We still do not understand the mechanism by which endometrial trauma may lead to improvements in IVF outcomes in women and further studies are needed looking specifically at its success among women undergoing their first IVF cycle.”

The papers are available here:

The Role of Natural Killer Cells in Human Fertility

Local Endometrial Trauma (Endometrial Scratch): A Treatment Strategy to Improve Implantation Rates

Should you pay for add-ons when having IVF?

proline_level_measurement_in_eurasian_national_universityWhether you are at the point of considering IVF or have already had some treatment, you will be aware of the wide range of additional treatments which some fertility clinics offer on top of the standard treatment cycle. The idea is that these will improve your chances of success, and as people inevitably want to do all they can to boost the likelihood of a positive outcome, it can be very tempting to pay for at least some of these.

It is clear that they will certainly add to the cost of your treatment, but whether they will add any benefits in terms of outcomes is still very much up for debate. Few of these add-ons have a reliable base of scientific evidence to prove that they are likely to work, yet patients are often paying for them believing that without them there is a lower chance of a successful cycle.

Yacoub Khalaf who is Director of the Assisted Conception Unit a Guy’s and St Thomas’ in London, spoke on the subject at The Fertility Show at the weekend. If you missed it, you may be interested in his article on the Huffington Post about this.

Taking part in clinical trials

proline_level_measurement_in_eurasian_national_universityPeople often email asking about clinical trials, and there are a couple of big multi-centre trials taking place at the moment which may be of interest. Taking part in a trial can be a really positive thing to do as you will be helping to improve understanding of techniques which may help make IVF more successful in future.
The first trial is called EFreeze and is investigating whether using frozen thawed embryos rather than fresh ones may lead to improved success rates in IVF. The theory behind this is that if the embryos are frozen rather than replaced straight away, the delay in embryo transfer means that any effects of the hormones used to stimulate the ovaries have worn off and the womb has time to return to its natural state.

Couples taking part in the study will be randomised to either have embryo transfer straight away as usual in IVF, or to have their embryos frozen and replaced later to see if this does improve outcomes. There is a lot of information for anyone considering taking part, including a list of participating centres, and a video to explain more on the trial web pages. You need to be under the age of 42 to take part in the trial which is being conducted across England and in Scotland.

The other trial is looking at endometrial scratch – a process which involves scratching the womb lining in the month before IVF treatment. There has been some research looking at this in women who’ve had repeated unsuccessful IVF cycles which suggest it may improve outcomes, but this new trial is looking at those who are having their first cycle. The study is based in Sheffield, but will be taking place at clinics around the country. It involves placing a small tube about the size of a drinking straw through the neck of the womb and gently scratching the womb’s lining.

Those taking part will be randomised to receive the scratch or not. If you want to find out more you can look at the information on the University of Sheffield website and there is a video to explain more about what is involved,

Should I have an endometrial scratch?

800px-Woman-typing-on-laptopIf you are having IVF treatment, you’ve probably read online about endometrial scratch – a procedure which involves “injuring” the lining of the womb and which apparently can increase the chances of an embryo implanting.

The procedure has been in the news this week after a new review of the trials of endometrial scratch was released which suggests it may be beneficial for couples who are either trying to conceive naturally or using IUI where it seemed to increase the chances of success considerably.  This has been widely reported as suggesting that everyone should go off and have a scratch but it is important to note that the review concludes that  “the quality of the available evidence is low”.

You can read more about the review presented at the European Society of Human Reproduction and Embryology here. There are currently trials being carried out looking at the success of endometrial scratch which should give some more good quality evidence to show whether or not the procedure is worth paying for.

Have you paid for extras when having NHS fertility treatment?

images-6Access to NHS-funded fertility treatment in the UK is still a postcode lottery, and what you get depends entirely on where you live. What’s also becoming more apparent is that in some areas people are paying for additional tests and treatment when they are having NHS-funded IVF or ICSI, but this doesn’t happen everywhere.

Some fertility patients are paying for time-lapse imaging, for endometrial scratch or for embryo glue for example – and others are reporting being asked to cough up for tests before treatment such as AMH tests or even sperm freezing and storage.

Your experience of extras for NHS-funded IVF 

The patient support charity Infertility Network UK is trying to build up a picture of what people are currently experiencing, so if you’ve paid for any additional tests or treatments on top of your NHS-funded IVF or ICSI, it would be really useful if you could let them know. All responses will be totally confidential, and you can email katebrian@infertilitynetworkuk.com.  If you have paid and are able to give a rough idea of how much you have paid this would be helpful, and they would also like to hear from you if you would have liked to pay for some extras but this was not permitted.

Want to know more about endometrial scratch?

I’ve noticed a lot of people have been asking about endometrial scratch recently and whether they should have it at their clinic alongside their IVF. It is a procedure which is sometimes offered alongside IVF and carried out before treatment starts. There have been suggestions that it may improve outcomes but it is clear that people aren’t really sure whether it is really worthwhile – and the costs of the procedure can vary hugely from one clinic to another.

Endometrial scratch – evidence and experience

If you want to find out more about other people’s experience of having a scratch, about the science behind it or about what leading specialists in the field would advise, you may be interested in this article I wrote on the subject for Fertility Road magazine. It will certainly help as a starting point if you aren’t quite sure whether to go ahead and pay for a scratch.

Have you tried endometrial scratch?

I’m really interested to know more about people’s experiences of endometrial scratch? If your clinic suggested it for you, or if you chose to have it done as part of your treatment and you might be willing to talk about it, can you get in touch via the contact page, leave a comment below or talk to me on twitter @katebrian?