Real-world management of male idiopathic infertility in indication for FSH treatment: a multicenter, longitudinal, observational cohort study (open registry)

Objective: The management of male idiopathic infertility is challenging. The Italian Medicines Agency (AIFA) note 74 regulates the empirical administration of follicle-stimulating hormone (FSH), although its application in clinical practice remain conflicting. The aim was to explore the management of male idiopathic infertility and to assess the actual use of FSH. Methods: A multicenter longitudinal prospective observational study (open-registry), involving 10 Italian Andrological and Gynecological Centers was carried out. Adult men with idiopathic infertility and serum FSH levels <8 IU/L were considered. Semen and hormonal parameters were recorded at baseline and after treatment. Results: 718 patients were enrolled (age 37.6±6.5 years). FSH treatment was prescribed in 55.3% of patients, with a significant difference between Andrological (61.3%) and Gynecological (30.3%) Centers (P<0.001). Recombinant-FSH was chosen in 64.5% and the urinary form in 35.5%. When prescribed, the adherence to regimen suggested by AIFA note (FSH at the dosage of 150 IU every other day) was almost complete (>90%). Concomitant hormonal treatment was prescribed to 23 patients (3.2%), nutraceuticals alone to 109 patients (15.2%), and nutraceuticals plus FSH for 42 patients (5.9%). Sperm concentration significantly increase compared to baseline (P=0.016) in patients treated with FSH. Conclusions: Only half of infertile patients are treated with FSH, although the note 74 guarantees this therapeutic approach. FSH treatment is more frequently prescribed by Andrological Centers, confirming the heterogeneous management of male infertility. This real-life analysis confirms the beneficial effect of FSH in male idiopathic infertility, although future properly-designed studies are needed to confirm this improvement.