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.

Will my IVF work?

ivf_science-300x168You may have heard about the new predictor tool for IVF/ICSI which has been developed recently which is available through the University of Aberdeen website.

It uses data from the Human Fertilisation and Embryology Authority which keeps records of all cycles of treatment carried out in the UK, to aim to give a picture of your individual chances of having a baby after IVF/ICSI treatment,

The reporting of this has been analysed by NHS Choices which points out that there are some gaps in the data which the researchers themselves have acknowledged as it doesn’t account for the woman’s body mass index (BMI), whether she smokes and how much alcohol she drinks.

Despite these limitations, it is certainly a very useful tool and one which may help many couples get some kind of realistic idea of the chances of an IVF cycle working. Of course, the experience of each individual couple is always different and this doesn’t allow you to include any detailed medical data either, but it does give a broad picture view which may prove very helpful.

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.

Choosing a fertility clinic

800px-Woman-typing-on-laptopOn Saturday, I’ll be speaking at the Fertility Show at London’s Olympia about what you need to think about if you are choosing a fertility clinic. If you are fortunate enough to have NHS-funded treatment, you may not have a wide range of clinics to choose from, and in some parts of the country there are fewer clinics than in others – but if you live in London or the South East and you are paying for your treatment, the choice can be overwhelming.

I’ll be explaining how to make sense of what can seem an overwhelming array of different clinics all claiming to be the best, and what factors you should take into consideration when making your choice. I’ll cover treatment outcomes – how to make sense of the IVF success rates published by the HFEA and why they may not be the only thing you want to look at when making a decision – and will look at a number of other issues that can affect which clinic might be right for you.

If you’re at the Show on Saturday, I look forward to meeting you – make sure you come and say hello!

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,

ICSI and the fertility of future children

DownloadedFile-17You may have heard about recent research suggesting that boys born after ICSI were likely to have lower sperm counts – and you may have been concerned about it. If you were, you may find this commentary from Bionews by Professor Allan Pacey of Sheffield University, who is one of the country’s leading sperm experts, reassuring.

There has always been a question about the future fertility of males born using ICSI, and it had been suggested that they might inherit their fathers’ fertility problems. The latest research has found that the sperm of ICSI-conceived men is of lower quality than average, but when fathers have particularly poor sperm quality this doesn’t seem to be passed on to their sons. You can read Professor Pacey’s interesting commentary on the subject here.

The brilliant NHS Choices also has a commentary on the research behind the headlines, and you can find that here.

Could your ethnicity affect your chances of IVF success?

120px-Pregnancy_test_resultNew research suggests that ethnicity may affect the chances of ending up with a baby after fertility treatment. A team from The University of Nottingham and the fertility unit at Royal Derby Hospital analysed data from the Human Fertilisation and Embryology Authority to see whether ethnicity had an impact on treatment outcomes, and found that there were some significant differences. According to the data, White British women are more likely to get pregnant with IVF or ICSI than women from a number of other ethnic groups.

This is the biggest study to look at the outcomes for individual ethnic groups in this way, and it considered the number of eggs collected and fertilised and the number of embryos produced as well as the pregnancy and live birth rate. The researchers also considered potential reasons for the differences in outcomes for the different ethnic groups and discuss factors such as genetic background, environment, diet, socio-economic and cultural factors and attitudes to medical care and accessing fertility treatment. They also discuss the fact that South Asian women are at higher risk of polycystic ovary syndrome (PCOS) which can affect egg quality and success rates.

You can find out more about this research here 

Do you really need ICSI?

images-6If you’d seen the Daily Mail headline earlier this week suggesting that the “Most popular form of IVF given to thousands of couples is ‘ineffective’“, you may well have been worried. In fact, the headline was referring to ICSI which is far from ineffective as a treatment for male fertility problems, and has allowed many men who would otherwise have had to use a donor to have their own genetic child.

The story in the Mail concerned the fact that ICSI isn’t an effective treatment in other cases, and it said that the editor-in-chief of the Human Reproduction journal, Professor Hans Evers, had criticised IVF clinics for offering ICSI to couples who will not benefit from it.

The fact that ICSI isn’t for everyone is not news. The NICE guidance in 2013 made it clear that ICSI should only be used where there were male fertility problems although it could also be considered where previous fertility treatment had resulted in failed or very poor fertilisation. ICSI is sometimes offered more widely, but there is no evidence that this would increase the chances of IVF working, and some research has suggested that it could actually reduce the chances of pregnancy where there is no indication that it is needed.

If you have male factor problems, you can ignore this as ICSI may well be the most effective treatment for you. If you are being offered ICSI where there are female issues or unexplained infertility, then you should make sure you talk to the team treating you about this before going ahead.

Fertility research – can you help?

Would you be able to spend a couple of minutes completing a quick questionnaire to help a research team?

They are keen to find out people’s views about time lapse imaging which some clinics are now offering with IVF/ICSI treatment. They want to assess whether fertility patients think a research trial to see how effective this is would be useful. You don’t need to have any personal experience of it but you do need to have had or be going to have IVF/ICSI.

If you have a spare couple of minutes, you can find their questions here – https://www.surveymonkey.com/s/66KDPTQ

When ICSI may not be best…

images-6ICSI (intracytoplasmic sperm injection) is a form of IVF that was developed to help overcome male fertility problems by injecting sperm directly into eggs, but in recent years is often used far more widely and sometimes in cases where there isn’t a male factor problem at all. Patients are often told that ICSI improves the chances of success, but a new study from the States has found that this is not the case unless there is a male fertility problem.  In fact, in cases where there is no male factor problem, ICSI is associated with lower rates of implantation and live birth than conventional IVF.

The research was a big retrospective study looking at more than 1 300, 000 IVF and ICSI cycles from 1996 to 2012.  The use of ICSI in the US in this period had gone up from 36% of cycles to 76%, but it was not associated with improved outcomes.

The research is published by the Journal of the American Medical Association, and you can read the full findings on their website – http://jama.jamanetwork.com