GM-CSF (sargramostim) treatment in women with recurrent implantation failure undergoing transfer of single healthy blastocyst after pgs: a randomized controlled trial

Abstract

The GM-CSF is a cytokine promoting leukocyte growth as well as trophoblast development. We described that this cytokine may be used in the treatment of recurrent abortion. We tested in this randomized controlled trial the use of GM-CSF (sargramostim) in the treatment for recurrent implantation failure in women undergoing IVF. A controlled randomized study conducted on women with Recurrent Implantation Failure. The study was conducted to the CERM, Rome, Italy, from the January 2016 to December 2017 on 73 women with recurrent implantation failure after IVF cycles. This study was approved by IRB. Inclusion criteria were: at least 9 good embryos previously transferred, women less than 38 years old, absence of systemic diseases. These women underwent IVF cycle and PGS on developed blastocysts. Single healthy blastocyst transfer was performed in the next cycle using only chromosomally healthy blastocysts. Patients were randomly divided in two groups: one (36 women) treated with subcutaneous GM-CSF 1.5mg/kg/daily (60-100) from the day of embryo transfer to the day of β-hcg day and if it was positive the treatment was continued for other 40 days: the control group (37 women) was treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcome was the pregnancy rate. Epidemiological data of the two groups did not show statistically significant differences. Pregnancy rate in the group treated with GM-CSF was 75.0% (27/36) whereas in the control group was 43.2% (16/37), P= 0.0087. No side effects were observed. The clinical use of GM-CSF in women experienced implantation failure may be useful, even though more studies are needed to confirm these findings.