title: Use of a fully automated injector for self-administration of follitropin alpha in an IVF/ICSI programme.
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(trade mark)) 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.
authors.affiliation: Centre for Reproductive Medicine, European Hospital, Via Portuense 700, 00149 Rome, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Greco
authors.forename: P
authors.initials: P
authors.lastname: Polonio-Balbi
authors.forename: S
authors.initials: S
authors.lastname: Ferrero
authors.forename: E
authors.initials: E
authors.lastname: Baroni
authors.forename: F
authors.initials: F
authors.lastname: Ubaldi
authors.forename: L
authors.initials: L
authors.lastname: Rienzi
authors.forename: J
authors.initials: J
authors.lastname: Tesarik
mesh_terms: D000328:Adult; D001007:Anxiety; D001331:Automation; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro / Q000295:instrumentation* / Q000379:methods*; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010053:Ovary / Q000187:drug effects; D010062:Ovulation Induction; D010146:Pain; D011247:Pregnancy; D018873:Pregnancy Rate; D011994:Recombinant Proteins / Q000008:administration & dosage; D020554:Sperm Injections, Intracytoplasmic / Q000295:instrumentation* / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone