In recent years, mean age of infertility patients at initial consultation appears to have increased and has been accompanied by a sharp rise in the number of prior failed IVF cycles [7
]. This refractoriness can be expected to result in higher interest in anonymous oocyte donation IVF, although how best to screen these oocyte recipients is not known with certainty. In Europe, regulations detailing mandatory testing for any IVF patients are lacking. The ESHRE Task Force on Ethics and Law (2002) carefully studied the matter of gamete and embryo donation, but did not recommend specific testing requirements for recipients. The issue of oocyte donation was addressed in more detail in the European Union Tissues and Cells Directive (Directive 2004/23/EC) [8
], yet testing guidelines for recipients of donated oocytes were again omitted. While this directive was designed to assure medical consumers of the safest possible healthcare rendered at the best possible standards, how exactly this objective should be applied to oocyte recipients remains undefined. Europe's key opinion leaders in reproductive medicine have questioned the appropriateness of applying this directive to general IVF practice [9
], and have highlighted the low yield (and increased patient expense) associated with an unnecessarily broad screening approach.
In Ireland, investigations focusing on screening data from non-donor IVF patients have likewise concluded that such individuals constitute a very low risk group, where the level of disease surveillance in this subgroup should be different compared to the general population. For Irish IVF patients and the physicians who offer this treatment here, the challenge to define proper testing is particularly acute given the absence of any legislation dealing with assisted reproductive techniques here [10
]. The current report is the first to aggregate screening data from recipients who underwent anonymous donor oocyte IVF in Ireland; no positive screens were identified among 225 consecutive IVF cases completed during the study interval. While our results are derived from a particular sub-group of IVF patients (i.e.
, anonymous donor oocyte recipients), these findings agree with general pre-fertility treatment screening data independently published from another leading Irish IVF centre [3
] where all test subjects also had negative screens. Taken together, these factors make it increasingly difficult to justify the current screening approach for IVF patients in Ireland as mandated by Directive 2004/23/EC.
Making sure patients have no serious infection before commencing fertility treatment is important. But since patients in our study all had negative tests performed with their GP or other primary care provider before embarking on IVF treatment, our (repeat) screening provided no additional clinically relevant information. We can therefore endorse the general view that re-screening of IVF patients in Ireland is not an effective method to enhance patient safety [3
]. Indeed, our study permits refinement and extension of their conclusions specifically to anonymous donor oocyte IVF recipients, where repeat HIV, Hepatitis B/C, syphilis, gonorrhoea, and chlamydia tests also yielded nothing but increased patient cost and potential anxiety. We believe that if such testing has already been carried out on the oocyte recipient in a previous (primary care) setting with negative results, then this is sufficient a priori
evidence that "best practice standard" has been met. Continued use of Directive 2004/23/EC to justify repeat testing for HIV, Hepatitis B/C, syphilis, gonorrhoea, and chlamydia specifically among recipients of anonymous donor oocyte IVF treatment is unwarranted in the absence of medical evidence to quantify risks for this patient population.