The recent Panorama documentary 'Inside Britain's Fertility Business' examined the issue of IVF 'add-ons' and looked at some of the conflicts of interest that can occur in private fertility care (see BioNews 880). It was a thought-provoking programme, which showcased an interesting combination of journalism and peer-reviewed scientific research.
As I watched, two thoughts occurred to me. The first was just what an ethical minefield the private fertility business is. The second was a nagging worry that we risk splitting reproductive technologies in two – a trustworthy and scientifically rigorous 'core' and, separate from this, the so-called IVF 'add-ons'. Add-ons are a range of additional investigations and treatments that are offered in addition to IVF as part of fertility treatment. The programme suggested that some of these interventions are unproven, lack stringent testing and are not cost-effective.
The accompanying BMJ article by Professor Carl Heneghan of the University of Oxford leaves no doubt that there are genuine concerns with the effectiveness and levels of evidence behind some of these 'add-ons'. But I fear that we may be tarring all additional interventions with the same 'add-on' brush. The interventions looked at during this study span a whole range of investigations and treatments, each with drastically different levels of evidence and underlying scientific research. The programme muddies the waters by failing to distinguish between cases where no research has been carried out, or where there is a lack of rigorous study, and those interventions that have actually been found to be ineffective.
It is difficult for clinics to decide which of these so-called 'add-ons' should be offered as part of their standard investigations and procedures. Some might be accused of profiteering by offering treatments that are of no benefit rather than putting their patients first. I think the perspective of a non-profit organisation could provide an interesting comparison.
Chana is a small charity which helps couples in the Jewish community deal with the challenge of infertility. It provides emotional and practical support and, in some cases, financial assistance to couples undergoing fertility treatment, so we have none of these conflicts of interest when considering the adoption of a new and often expensive methodology.
Chana has recently begun to incorporate sperm DNA damage testing into its existing services. Testing for sperm DNA damage is a new technique that has begun to enter clinical practice. High levels of DNA damage in sperm are associated with reduced reproductive outcomes, including lower rates of conception, reduced success at IVF and early pregnancy loss. Clinicians currently rely on conventional semen analysis alone to diagnose male-factor infertility, but this is no more than a rough guide for differentiating between 'probably fertile' from 'probably sub-fertile' and is a poor predictor of fertility treatment outcome. While everyone agrees about the need to improve male-fertility diagnostics, there is extensive debate on the clinical usefulness of testing sperm for DNA damage. However, there are thousands of scientific research papers spanning several decades on this particular 'add-on'.
Two clinical scenarios helped us to decide to include sperm DNA damage testing in Chana's standard procedures. The first was seeing patients who presented after several failed IVF attempts. Men with high levels of sperm DNA damage have been shown to be more likely to achieve a pregnancy with ICSI than with IVF. Therefore, testing sperm for DNA damage early on in the process provides additional information and can lead to a distinct change in clinical practice, saving couples from unnecessary distress and disappointment. As a charity with limited funds, we also realised that the cost of this extra diagnostic test would likely be made up for by the failed cycles of IVF that were avoided as a result. The second scenario was that of patients presenting with fertility problems combined with recurrent early pregnancy loss. There is a significant increase in miscarriage in couples with high sperm DNA damage compared with those with low DNA damage. Testing for sperm DNA damage could help explain the underlying cause of the recurrent miscarriage.
Among couples with unexplained infertility, the existence of sperm DNA damage could provide a possible explanation, even if no medical course of action is indicated. The peace of mind an explanation for infertility gives serves an important psychological purpose and, while hard to value, should not simply be ignored.
Evidence supporting different fertility interventions can vary drastically, and it is important to judge the appropriateness of any given 'add-on' on an individual basis. Private fertility clinics must put patients first and provide clear, honest and reliable advice and must not take advantage of vulnerable patients at a difficult time in their lives.
The Progress Educational Trust event 'Fertility Treatment Add-Ons: Do They Add Up?' on 29 March is now oversubscribed and further bookings are not being taken.