A Randomised Controlled Trial on the Treatment of Recurrent Implantation Failure Women Who Failed Egg Donation Cycles Using Low-Dose GM-CSF.

PROBLEM: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a cytokine promoting leukocyte proliferation and trophoblast growth. Recurrent implantation failure (RIF) is the repeated failure to reach pregnancy in IVF cycles. In this randomized controlled trial, the use of low dose of GM-CSF in the treatment of RIF in egg donation cycles was tested.

METHODS OF STUDY: A randomized controlled trial was conducted on women with RIF after egg donation cycles. The inclusion criteria were age between 30 and 49 years old: at least three previous transfers failed with good quality blastocysts in egg donation cycles: no uterine defects. The patients were randomly subdivided into two groups: one treated with subcutaneous GM-CSF 0.3microg/kg/day from the day before embryo transfer to the b-hCG day. Since RIF patients may be at risk for miscarriage, this treatment was continued until the eighth week of gestation to avoid possible early miscarriage. The control group was treated with a subcutaneous saline solution infusion in the same way as the study group. Primary outcomes were the clinical pregnancy rate and live-birth rate.

RESULTS

Epidemiological data of the two groups did not show statistically significant differences. The clinical pregnancy rate in the GM-CSF group was 73.5% (39/53), while in control group it was 34.6% (18/52) (p < 0.0001), the live-birth rate was 67.9% (36/53) and 28.8% (15/52), respectively (p < 0.0001).

CONCLUSION

The clinical use of GM-CSF in women who experienced implantation failure may be a useful treatment in a selected group of patients. The model of women with RIF after egg donation, at the light of our results, may be considered a valid model to study this clinical entity.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01715974.