Endocrine Abstracts

Introduction: Male idiopathic infertility represents a therapeutic challenge for physicians, since a targeted aetiological treatment does not exist. Several hormonal and non-hormonal therapies have been proposed so far to increase pregnancy rates. Among hormonal therapies, exogenous follicle-stimulating hormone (FSH) administration shows the most convincing physiological rationale in the face of a clinical efficacy below expectations. Indeed, from evidences available in the literature, it was calculated that 10 to 18 men have to be treated to achieve one only pregnancy. This result comes from the published controlled clinical trials, but only few data are currently available on the real FSH effectiveness in clinical practice.

Aim: To assess the effectiveness of FSH administration in male idiopathic infertility in a clinical setting.

Methods: An interim analysis of a retrospective, observational, monocentric, real-world study was performed. All consecutive male outpatients attending the Andrology Unit of Modena (Italy) for couple infertility were enrolled. According to the reimbursement rules of the Italian Health System, FSH could be prescribed to men with idiopathic infertility and FSH serum levels <8 UI/l. Collected data included medical history, physical and andrological examinations, sex steroid hormones, conventional semen analysis and therapeutic choice.

Results: 201 infertilemen were enrolled (mean age 37.6±6.2 years), presenting mostly (91.2% of cases) for primary couple infertility. At baseline, 17 patients (12.4%) showed normozoospermia, 25 subjects resulted azoospermic (12.5%), while a variable degree of semen parameters impairment was recorded in 159 men (75.1%). Among 161 patients potentially eligible for exogenous FSH administration, 54 patients (33.1%) received hormonal therapy. FSH-treated patients showed significantly lower baseline FSH levels (3.5±1.8 vs 8.9±10.9 IU/l), sperm concentration (8.2±8.4 vs 29.7±26.5 millions/ml) and sperm motility (5.1±8.6 vs 25.7±18.9%) compared to FSH-untreated men. Comprehensively, nine pregnancies were obtained in FSH-treated patients (16.7%), one spontaneous and eight after assisted reproduction procedures.

Conclusion: From our single centre experience on FSH treatment in male idiopathic infertility, it emerged that FSH is currently administered to men with low baseline FSH levels and impaired semen parameters. Our experience suggests that FSH empirically administered leads to pregnancy in 1 on 6 patients treated. Despite this study lacks a control group in a real world setting, the number of patients required to achieve a pregnancy seems to be lower than what calculated on published data.