What you need to know about HFEA if you are having IVF treatment

If you have had IVF or IUI before you probably already know who they are or have seen an additional cost on the end of your invoice attributed to HFEA.

Who are they?  HFEA stands for Human Fertilisation and Embryo Authority, they are an impartial independent regulator of fertility treatment and research using human embryos. They are responsible for licensing, monitoring and inspecting fertility clinics independently from the government.

How are they funded?  Mainly by the Fertility Clinics they regulate.  Clinics must apply and pay for a license every 4 years, on top of this each IVF or IUI cycle undertaken in the UK incurs a fee payable by the clinic to HFEA which is included in the fee to the client.  They also receive a government grant.

Interesting Stats

• 60,000 patients per year use fertility services in the UK
• 60% pay for the treatment themselves
• Single embryo treatment is more common place since 2019.  A single embryo is transferred  in 75% of IVF cycles compared to 13% in 1991
• Use of doner eggs has increased the chance of a live birth to over 30% in all age groups.  However, only 17% of 40+ opted for donor eggs in 2019
• From late 2023 onwards, most donor-conceived people in the UK turning 18 will be able to apply to the HFEA to access identifying information about their donors

Treatment Add ons – optional adjuncts which incur an additional payment

An interesting source of information on treatment add ons provided in fertility clinics has been published on their website.  Using a traffic light system they have rated the most common add ons which, according to the evidence provided by Random Control Trials (RCT),  show that they are effective in improving the chances of having a baby in “most couples undergoing fertility treatment”.  It is an interesting read and I’ll summarise it here along with my POV, which is that many of the add on’s have a very specific patient group for which they are suitable for and it may not be the majority of people that have IVF i.e. most couples.  Additionally some of these add ons have other important benefits concerning the well being and mental health of the patient and in these situations some of the Amber and Red add ons may be an important part of overall treatment.

Green – denotes that 1 or more high quality RCT has been carried out and illustrates the procedure is effective in improving the chances of having a baby for most couples – e.g. intracytoplasmic injection ICSI.  Bearing in mind that ICSI is not a suitable treatment option for all couples, and is used mainly for male factor issues.  Or at least it should be – but that’s another story!

Amber – stands for conflicting or non conclusive evidence in RCT’s that the add on improves chances of having a baby for most people.  Here they have cited

• elective freeze all embryos – this is often referred to as “Batching”, so a couple may have 2 or 3 cycles and freeze all before using the best embryos from all the cycles for transfer.  It obviously has clear benefits and is the correct treatment pathway for clients who experience OHSS (ovarian hyper stimulation), but it gets my vote as more of a “protocol” – for some the relief of not having to rely on one cycle for success is transformative and much less stressful it also gives the patient a breather after the intensive stimulation phase.
• endometrium scratch – I have not seen many clients in my clinic for whom this has made much difference to their success rate.  It was more popular 6-7 years ago and I rarely see this add on in use now.
• embryo glue – similar to the endometrial scratch – though I know its frequently offered
• time-lapse imaging – this is a useful bit of kit – over 1000 images of the growing embryo are taken whilst it is developing in the incubator – the embryologist is able to monitor this without removing them albeit briefly. It is early days and there is not sufficient enough evidence to prove that the quality of the embryo is improved by being disturbed less, but it seems likely it will become available.  My feeling is, if you have the kit at the clinic and clients are paying for clinical excellence, how do you justify this as an extra cost – surely it should be available for all embryos.

Red – no evidence from RCT is available to show that it is effective in improving chances of having a baby for most people

• IMSI – this is ICSI with a better microscope for choosing the sperm – suitable for specific groups e.g. age 38+ and couples with unsuccessful ICSI.  For anyone else this is not worth the extra cash.
• PGT-A – pre genetic testing for aneuploidy (embryo’s that have a chromosome issue) anyone who has discussed this with me in clinic knows that I have mixed feelings about this.  Anyone having it done must prepare for the fact that they may end up with no embryos to transfer if all their embryos come back as aneuploidy which can happen.  Obviously the more embryos you have the more chance you have of a chromosomal normal embryo, most clinics will test up to 5 for one price (around £1,000) so it is more cost effective the more you have.  My reservations have been around the possibility of damaging the embryo when extracting stem cells, and also the fact that often a definitive answer is elusive with some embryos (morula) coming back with an inconclusive result.  However, more and more I am seeing the psychological benefits to clients (particularly those who have been through multiple miscarriages) of being able to transfer a chromosomally sound embryo.
• Immunology Testing and Treatment – this is a big subject and too detailed for here, it includes NK (Natural Killer) cells and cytokine ratios, and has been controversial for years, but I am surprised there is not some conclusive evidence for use of the steroid prednisolone for NK cells at the very least.  The issue is two-fold, there is a lack of belief in the rationale of the immune NK cells rejecting the embryo and secondly the that the treatment itself has any efficacy and indeed could be harmful.  In my clinic, for women with multiple miscarriages and unexplained difficulty in getting pregnant, who go on to test for activated NK cells and then take the treatment offered,  a large majority of them will have the baby of their dreams.  It’s not an easy route and it may take some time but I’ve seen more success then failure once diagnosed.
• ERA – Endometrial Receptivity Array – the endometrial tissue is taken for biopsy in a mock transfer.  It is then tested to see when the optimal time is for transferring back to the uterus rather than assuming it’s 5 days (for a blastocyst).  I have seen a few (not many) of these cases in my clinic especially with women who have endometriosis with good results.  There is also a RCT which is quite promising, again the key cohort of clients this is especially suitable for is not the whole population.

So the traffic light system is helpful but it doesn’t give the full picture.  If you are ever in doubt and your clinic is keen for you to purchase an add on, do some research before signing on the dotted line – it all adds up.  Also, feel free to get in touch with me or other fertility support trained acupuncturists.