Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)

NCT01202656 ↗

Phase 1/2 Completed 129 enrolled Center for Human Reproduction Foundation for Reproductive Medicine · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.

Timeline

Start: 2010-09
Primary completion: 2012-12
Completion: 2013-06

Outcome

Missed primary endpoint

registry G-CSF vs Saline; p = 0.72; Cochran-Mantel-Haenszel NCT01202656 ↗

paper Statistical models looking at treatment effects on clinical pregnancy and implantation rates demonstrated no effect of G-CSF treatment. PMID 24424357 ↗

Publications

Results Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. 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. Fertil Steril. 2014 Mar;101(3):710-5. doi: 10.1016/j.fertnstert.2013.12.016. Epub 2014 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	G-CSF	Unknown	300 ug	Other
Subject	G-CSF	Unknown	300 iu	Other