Modification of peripheric Treg and CD56 bright NK levels in RIF women after egg donation, treated with GM-CSF or placebo.

Recurrent implantation failure (RIF) is defined as when implantation repeatedly failed to reach a stage recognizable by pelvic ultrasound in IVF cycle and it may be due to several causes. The GM-CSF is a cytokine promoting leukocyte growth and trophoblast development: we tested it to treat these patients in a pilot-controlled trial evaluating the modification of peripheric Treg and CD56bright NK levels after the treatment with this cytokine and in control patients affected by RIF after egg donation cycles. This study was performed on 24 RIF women after egg donation cycles. Single good quality blastocyst transfer was performed in the cycle object of this study. Patients were randomly assigned to two groups: 12 women treated with subcutaneous GM-CSF 0.3 mg/kg/daily from the day before embryo transfer to the β-hCG day, and 12 women treated with subcutaneous saline solution infusion as control. All patients were tested for Treg and CD56bright NK cell levels in blood circulation before and after treatment using flow-cytometry with specific antibodies. The two groups of patients were similar for epidemiologic characteristics, the ongoing pregnancy rate in the GM-CSF group was 83.3% whereas in the control group was 25.0% (P = 0.0123). In the study group there was a significative increase of Treg cells (P < 0.001) with respect to the levels before treatment and to control group. Instead, the levels of CD56bright NK did not show any significative variation. Our study showed that the treatment with GM-CSF increases the Treg cells in the peripheric blood.