Recombinant FSH (r-FSH) used for ovarian stimulation can currently be self-administered either by a conventional syringe or by a pen device. This randomized controlled trial compares the efficacy and convenience of a new, more sophisticated and fully automated injection device (Softinject(TM)) with the conventional syringe for r-FSH self-administration. A total of 300 women needing ovarian stimulation for IVF/intracytoplasmic sperm injection were randomized to the automated injector or the conventional syringe group. Patients of both groups had ovarian stimulation with follitropin alpha after pituitary desensitization with a gonadotrophin-releasing hormone agonist. State anxiety score, overall pain score and pregnancy rate were chosen as the main outcome measures. Patients in the automated injector group showed lower state anxiety (P < 0.01) and overall pain (P < 0.01) scores and a comparable pregnancy rate per started cycle as compared with the conventional syringe group. They needed lower doses of r-FSH (P < 0.05) and their stimulation was shorter (P < 0.05). It is concluded that the use of a fully automated injector for r-FSH self-administration reduces pain and stress as compared with the conventional syringe. This device can be used for any subcutaneously administered drug employed in ovarian stimulation.
Use of a fully automated injector for self-administration of follitropin alpha in an IVF/ICSI programme
Greco, Ermanno;
2005-01-01
Abstract
Recombinant FSH (r-FSH) used for ovarian stimulation can currently be self-administered either by a conventional syringe or by a pen device. This randomized controlled trial compares the efficacy and convenience of a new, more sophisticated and fully automated injection device (Softinject(TM)) with the conventional syringe for r-FSH self-administration. A total of 300 women needing ovarian stimulation for IVF/intracytoplasmic sperm injection were randomized to the automated injector or the conventional syringe group. Patients of both groups had ovarian stimulation with follitropin alpha after pituitary desensitization with a gonadotrophin-releasing hormone agonist. State anxiety score, overall pain score and pregnancy rate were chosen as the main outcome measures. Patients in the automated injector group showed lower state anxiety (P < 0.01) and overall pain (P < 0.01) scores and a comparable pregnancy rate per started cycle as compared with the conventional syringe group. They needed lower doses of r-FSH (P < 0.05) and their stimulation was shorter (P < 0.05). It is concluded that the use of a fully automated injector for r-FSH self-administration reduces pain and stress as compared with the conventional syringe. This device can be used for any subcutaneously administered drug employed in ovarian stimulation.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.