An open-label, single-center, pilot study.
Assisted conception unit of a university hospital.
Twenty patients undergoing COH over a 3-month period.
COH was carried out using a fixed dose of rFSH administered via the J-Tip System in a GnRH antagonist cycle.
The primary endpoint was the mean number of oocytes collected per patient, and secondary endpoints were incidence of technically correct injections, clinical pregnancy, and cancellation rates. Patient diaries were kept throughout the study.
Sixteen patients completed the trial, four of whom became pregnant, with a high overall satisfaction rate.
This is the first report of the use of the novel J-Tip Needle-Free Injection System for administration of gonadotropins in IVF with successful ovarian stimulation and achievement of pregnancies. This report indicates that this technique is associated with minimal pain and high patient acceptability. Large-scale multicenter studies are required to examine the reproducibility of these results and the J-Tip's cost-effectiveness as well as to compare the J-tip System with conventional needle-wise administration for COH before its introduction into routine IVF practice.