An inconvenient truth: ICSI is not necessary for the majority of IVF patients

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.