IVF Add-Ons – Are they worth the expense?

Many couples turn to IVF in pursuit of creating a family. These couples put their absolutely trust in their clinic and doctor to provide them with the most up to date and research based treatments and investigations. However there is increasing concern that many of the additional treatments and services 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. Add-ons increase this financial burden. An endometrial scratch, for example, can cost over £300, time lapse imaging up to £850 and pre-implantation genetic screening (PGS) in the region of £3500

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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 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

Out of the 38, 13 treatments or interventions had clear recommendation by NICE and were scientifically researched and 2 were not recommended:

Interventions Recommended                                          Not Recommended

AMH and Antral Follicle Count testing                                Hysteroscopy

Unstimulated Cycle IUI                                                         Assisted Hatching

Frozen Embryo Transfer

Surgical Sperm Retrieval

Egg/Embryo Freezing

ICSI                                                                                                      

Vitrification of eggs/embryos

Sperm freezing

Ovulation induction and cycle monitoring

Sperm DNA test

Thyroid Antibody testing

19 Interventions were not mentioned by NICE or the recommendations were unclear:

SpermSlow

Blastocyst Culture

Time Lapse Embryo Imaging

IMSL

Endometrial Scratching

Adherence compounds

Endometrial Receptivity Array

Early Embryo Transfer

PGS

Stimulated IUI Cycle

AneVivo

Segmented IVF

Oxidative Stress Levels in Semen

Dummy Embryo Transfer

Early Embryo Viability Assessment

Ovarian Tissue Freezing

Artificial Oocyte activation

 

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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)):

Blastocyst Culture

Endometrial Scratching

Adherence Compounds

Oral Antioxidants

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

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.

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!

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Heneghan C et al (2016) Lack of evidence for interventions offered in UK fertility centres. BMJ 2016;355:i6295 (Accessed online: 30/11/16)

HFEA (2016) Statement on fertility treatment ‘add-ons’

(Accessed online 30/11/16)

 

 

Credit: Images sourced from Google