[Improving treatment outcome by LeukoNorm Cytochemia in patients with multiple, failed IVF or ICSI treatment cycles]

The aim of these studies was to investigate whether the leucocytic ultrafiltrate LeukoNorm Cytochemia, which is approved for the treatment of immunologically-based recurrent spontaneous abortions (RSA), improves treatment results in patients with repetitive IVF or ICSI failures.

Included in this study were patients with 3 embryo transfers, with at least 8 morphologically good-looking embryos of the categories a and b, and no conception. Excluded were patients with accompanying endocrine disorders, uterine malformations, and those exhibiting the presence of an antiphospholipid syndrome and of further autoantibody syndromes (e.g. antinuclear antibodies [ANA]). The patients were treated in three prospective, randomized studies. The studies differed with respect to the frequency and timing of the administration of LeukoNorm Cytochemia.

Pregnancy rates in each of the study protocols were generally higher than in the normal treatment group. Because of the small number of patients (study I: 10 patients), the differences were not always significant. The results of study III, which is still ongoing and in which LeukoNorm Cytochemia has been given on 5 consecutive days starting with the day of oocyte retrieval, are more significant. In the treatment group of study III the pregnancy rate was 55% as opposed to a rate of 21.2% in the non-treatment group.

The administration of LeukoNorm Cytochemia can significantly improve treatment results in patients with repetitive IVF or ICSI failures. Currently the most favourable results are observed with a dosage of 1 unit/10 kg on 5 consecutive days, starting with the day of oocyte retrieval. These results imply that, in the IVF or ICSI programmes, there exists a group of patients with disturbances in the embryo-maternal dialogue, and therefore no conceptions. Furthermore, the results demonstrate that the administration of LeukoNorm Cytochemia can improve the implantation rate of transferred embryos in these patients. We conclude that growth factors and cytokines synthesized and secreted by leucocytes have an important influence on embryonic implantation and growth.