Effect of Intrauterine Perfusion of Granulocyte Colony-stimulating Factor on Endometrial parameters and Fertilization Outcome in Women Undergoing Fertilization/Intracytoplasmic Sperm Injection Cycles: A Randomized Controlled Trial.

CONTEXT

Studies have found intrauterine perfusion of granulocyte colony-stimulating factor (G-CSF) to improve endometrial thickness and implantation rates in women undergoing fertilization (IVF).

AIMS

To study the effect of intrauterine perfusion of G-CSF on endometrial parameters and IVF outcomes in patients undergoing fresh embryo transfers.

SETTINGS AND DESIGN

This was a randomized double-blinded placebo-controlled trial conducted at assisted reproduction unit of a tertiary care center.

SUBJECTS AND METHODS

One hundred and fifty patients undergoing IVF/intracytoplasmic sperm injection (ICSI) treatment and fresh embryo transfers were randomized to intervention and placebo groups. Patients in the intervention group received intrauterine perfusion of 300 μg (0.5 ml) of G-CSF on the day of ovulation trigger. Patients in placebo group received intrauterine perfusion of 0.5 ml normal saline on the day of ovulation trigger. The primary outcome measure was clinical pregnancy rate. The secondary outcome measures were change in endometrial thickness, volume, and vascularity on the day of embryo transfer; biochemical pregnancy rate, implantation rate, ongoing pregnancy rate, and live birth rate. Statistical analysis was carried out using STATA 12.0 (StataCorp LP, College Station, Texas, USA).

RESULTS

Endometrial vascularity in the intervention group was significantly higher on the day of embryo transfer compared to the placebo group. Clinical pregnancy rate was 27.6% in the intervention group compared to 18.9% in the placebo group and the difference was not statistically significant ( = 0.207). There was no statistically significant difference between biochemical pregnancy rate, implantation rate, ongoing pregnancy rate, live birth rate and endometrial parameters between the two groups.

CONCLUSIONS

Routine use of G-CSF in unselected IVF cycles may not lead to increase in positive IVF outcomes. More trials with larger sample sizes are required before approving or refuting the role of routine G-CSF in increasing IVF success rates. (CTRI/2017/10/010310).