Should you consider IVF Add-ons?
Fertility problems affect one in seven couples in the UK. Many of these couples go on to seek assisted conception. However there is increasing concern that many of the additional treatments and services, often termed IVF Add-ons, offered by fertility clinics in the UK are not research based and are therefore misleading patients, increasing their financial burden and ultimately offering little more than false hope.
IVF is expensive, especially when less than half the procedures receive NHS funding. IVF Add-ons increase this financial burden. An endometrial scratch, for example, can cost over £300, time lapse imaging up to £850 and preimplantation genetic screening (PGS) in the region of £3500
Research conducted at the Centre for Evidence-Based Medicine in Oxford (Heneghan et al 2016), aimed to assess IVF Add-Ons offered in all UK Fertility clinics against the following criteria:
- Are the IVF Add-Ons recommended by the National Institute for Health and Care Excellence (NICE)?
- Have Randomised Controlled Trials (RCT’s) been conducted to prove that the treatment or intervention is effective?
- Are there any risks or adverse effects associated with the treatment or intervention?
Following the assessment of the website of Fertility Clinics in the UK, the researchers were able to identify a total of 38 interventions and classified these as 27 IVF Add-On, 6 alternatives to IVF and 5 treatments for fertility preservation.
NICE Recommendations and IVF Add-ons
Out of the 38, 13 treatments or interventions had clear recommendation by NICE and were scientifically researched and 2 were not recommended:
IVF Add-ons Recommended Not Recommended
AMH and Antral Follicle Count testing Hysteroscopy
Unstimulated Cycle IUI Assisted Hatching
Frozen Embryo Transfer
Surgical Sperm Retrieval
Vitrification of eggs/embryos
Ovulation induction and cycle monitoring
Sperm DNA test
Thyroid Antibody testing
19 Interventions were not mentioned by NICE or the recommendations were unclear:
Time Lapse Embryo Imaging
Endometrial Receptivity Array
Early Embryo Transfer
Stimulated IUI Cycle
Oxidative Stress Levels in Semen
Dummy Embryo Transfer
Early Embryo Viability Assessment
Ovarian Tissue Freezing
Artificial Oocyte activation
RCT’s and Systematic Reviews
Systematic reviews combine data from multiple RCT’s and therefore provide an accurate assessment of whether a treatment or intervention is effective.
27 of the 38 fertility interventions were found to have a relevant systematic review. These reviews reported that only 5 of the 38 interventions improved live birth outcomes (The remaining interventions were categorised as the evidence being insufficient (13) or did not improve live birth rate (7)):
Natural Cycle IUI
However, the methodology for all 5 of these studies had various flaws which raises questions surrounding the robust nature of the current evidence, and hence the most likely reason for their lack of inclusion within the NICE recommendations.
Risk or Adverse Effects of IVF Add ons
There was found to be very little information with regards risk and adverse effects in general.
NICE were only able to provide comment for 2 interventions. For ovulation induction it is recommended that the lowest effective dose be used and for the shortest duration. For IVF with or without ICSI, NICE recommend that women should be informed that the risk of long term adverse outcomes are low but there is a small increased risk of ovarian tumours.
One review paper identified that PGS was found to worsen outcomes and this was especially so of the older PGS techniques. There was some evidence of benefit for the newer PGS techniques.
Where do we go from here?
The very organisation that should be protecting vulnerable patients, the Human Fertilisation and Embryology Society (HFEA) is letting couples down. Questions are being raised as to why the HFEA is not regulating the treatments and interventions that are not research based within UK clinics? A statement on the HFEA website states that ‘’We are concerned about the recent step change in the use of treatment add-ons. Unfortunately, we have limited powers to stop clinics offering them, nor to control pricing.’’ Adding that instead the society publishes information directly for patients, to enable them to make informed decisions. However is this enough? Couples are very likely to feel desperate and facing their Doctor whom they trust to be acting in their best interest, will try anything, but at what cost?
This research has shown that couples seeking fertility treatment need better information that is grounded in scientific research to enable them to make informed choices. They need greater information about the potential risk and adverse effects of treatment. Clinicians have a responsibility to inform patients if a particular treatment they recommend is research based and if not, why not?
Hopefully this research from Oxford has raised some important aspects that can’t be ignored and we will start to see some changes and potentially greater regulation within our fertility clinics. In the meantime, don’t be afraid to question your doctor about the efficacy of the treatments recommended, after all you hold the purse strings!