Professor Lisa Jardine, chair of the Human Fertilisation and Embryology Authority (HFEA) has recently criticised the overuse of intra-cytoplasmic sperm injection (ICSI), the same concern having been voiced by Professor Andre Van Steirteghem back in 2010 and Professor Rob Norman back in 2009, both recognised opinion leaders in IVF in the northern and southern hemispheres. Despite their views, the increased use of ICSI continues unabated, so why is nobody listening?
It has long been accepted that the incidence of male factor infertility in cases of fertility treatment is only 30 to 40 percent at most. However, data from the HFEA and the National Perinatal Statistics Unit shows that ICSI is now used to treat 53 to 68 percent of all couples receiving fertility treatment in the UK and Australasia, respectively. Clearly, there is a major discrepancy between the observed rate of male factor infertility and the reported use of ICSI.
The explanation for this is not readily apparent, but the disproportionate use of ICSI could be due to several factors, including the assumption that ICSI will avoid fertilisation failure and will result in a higher pregnancy rate. But is there really any good evidence to support this view?
Some IVF practitioners advocate that all couples should be treated with ICSI, but concerns over its long-term safety have been raised recently (1). Furthermore, one of the cornerstones of evidence-based medicine, the Cochrane library, reported no superiority of ICSI over IVF in pregnancy rates for couples with non-male factor infertility (2). As proof of principle, and contrary to the national trend towards an annual increase in the use of ICSI, my colleagues and I have successfully treated at least 60 percent of our couples with conventional IVF alone every year in both the private and public sector over the past 15 years.
We retrospectively analysed data from over 3,000 cycles of treatment during the period 2004-2007 where, as usual, only 40 percent of the patients were treated with ICSI (3). Fertilisation and clinical pregnancy rates were 71 percent and 30 percent for IVF, and 66 percent and 33 percent for ICSI, respectively, and the failed fertilisation rate for all patients was only 3 percent. As one should expect, our rate of ICSI usage is consistent with the observed incidence of male factor infertility without any significant difference between our IVF and ICSI data.
A number of similar studies have been recently reviewed (4), demonstrating that ICSI does not improve clinical outcomes for unexplained infertility, low egg yield and advanced maternal age, concluding that there is no data to support the routine use of ICSI for non-male factor infertility. However, a recent survey of ICSI in the UK revealed its usage to range wildly - 21 percent to over 80 percent of patients being subjected to ICSI despite HFEA data failing to demonstrate an increased live birth rate in those centres that use ICSI more frequently (5). Should we be concerned about this varied and apparently relaxed use of ICSI?
Since ICSI is a more costly process to the patient, the IVF centre, and the Department of Health (6), it is difficult to justify its use in patients that clearly do not require it to resolve their sub-fertility. A benefit/risk/cost analysis would surely demonstrate IVF to be the better option for the majority of patients. The public would certainly be better informed if IVF and ICSI fertilisation rates were compared, reported and advertised per egg collected rather than per egg inseminated, which otherwise always skews the data in favour of ICSI since not all eggs are injected whereas all eggs are inseminated with conventional IVF.
Equivalent funding of IVF and ICSI treatment might also redress the increasingly disproportionate use of ICSI. Ultimately, we all want our patients to have a healthy baby using the most appropriate and safest means at our disposal, without it costing them or the taxpayer more than necessary.