Effect of Granulocyte Colony Stimulating Factor (GCSF) on Live Birth Rate in Women With Unexplained Infertility After Intrauterine Insemination: a Randomized Clinical Trial
Abstract Background: to evaluate the effect of granulocyte colony stimulating factor (GCSF) on fertility outcomes in women with unexplained infertility after intra uterine insemination (IUI).Methods: The patients with unexplained infertility were divided into two groups: one group was received GCSF in their IUI cycle and the other group had the routine IUI. Both groups were stimulated by letrozole, metformin and monotropin during the cycle. When at least one follicle was greater than 18mm, 5000 IU hCG intramuscularly was administered for ovulation induction and IUI was performed 34-36 hours later. In intervention group, 300 ug GCSF subcutaneously administrated in two days after IUI. The main outcome measures were biochemical pregnancy, clinical pregnancy, abortion rate and live birth rate.Results: There was no significant difference in demographic and clinical characteristics between the control group and the G-CSF group. Also, no statistically significant difference was identified in the biochemical pregnancy rates (16.3% vs 12.2%), clinical pregnancy rates(16.3% vs 8.2%), abortion rates (0 vs 2.04%) and live birth rates (8.2% vs 14.2%) between the control group and the G-CSF group (P=0.56, P=0.21, p=0.55 and p=0.32 respectively). Conclusion: Systemic administration of a single dose of 300 μg GCSF subcutaneously two days after IUI may slightly improve clinical pregnancy rate and live birth rate in patients with unexplained infertility. Nevertheless, our findings do not support routine use of G-CSF in unexplained infertility women with normal endometrial thickness. IRCT registration number: IRCT20160524028038N4.