A randomized clinical trial of endometrial perfusion with granulocyte colony stimulating factor in in vitro fertilization cycles Impact on endometrial thickness and clinical pregnancy rates

Capsule:
Granulocyte colony-stimulating factor neither affects endometrial thickness nor pregnancy rates in normal in vitro fertilization patients.

Authors:
David H. Barad, M.D., M.S., Yao Yu, Ph.D., Vitaly A. Kushnir, M.D., Aya Shohat-Tal, Ph.D., Emanuela Lazzaroni, M.S., Ho-Joon Lee, Ph.D., Norbert Gleicher, M.D.

Volume 101, Issue 3, Pages

Abstract:

Objective:
To investigate whether granulocyte colony-stimulating factor (G-CSG) affects endometrial thickness, implantation rates, and clinical pregnancy rates in routine, unselected IVF cycles.

Design:
Registered, individually randomized, two-group, parallel double-blinded placebo-controlled clinical trial.

Setting:
Academically affiliated private clinical and research center.

Patient(s):
141 consecutive, unselected, consenting women with no history of renal disease, sickle cell disease, or malignancy who were undergoing IVF.

Intervention(s):
Sealed, numbered, opaque envelopes assigned 73 patients to receive G-CSF (Filgrastim, Amgen, 300 μg/1.0 mL) and 68 to receive placebo (saline).

Main Outcome Measure(s):
Endometrial thickness, clinical pregnancy, and embryo implantation rates.

Result(s):
The mean age for the whole study group was 39.59 ± 5.56 years (G-CSF: 39.79 ± 5.13 years; placebo: 39.38 ± 6.03 years). Endometrial thickness statistically significantly increased over the 5-day observation period for the whole group by approximately 1.36 mm. The increase in the G-CSF group was not statistically significantly different from the control group. Statistical models looking at treatment effects on clinical pregnancy and implantation rates demonstrated no effect of G-CSF treatment. There were no adverse events for either treatment group.

Conclusion(s):
In normal IVF patients, G-CSF does not affect endometrial thickness, implantation rates, or clinical pregnancy rates. Because these results were obtained in an older patient population, they may not necessarily apply to younger women.