Clinical Guidelines and Standards · Guidelines by Clinical Area
The Italian Society of Andrology and Sexual Medicine (SIAMS), along with ten other Italian Scientific Societies, guidelines on the diagnosis and management of erectile dysfunction
Corona G,Cucinotta D,Di Lorenzo G,Ferlin A,Giagulli VA,Gnessi L,Isidori AM,Maiorino MI,Miserendino P,Murrone A,Pivonello R,Rochira V,Sangiorgi GM,Stagno G,Foresta C,Lenzi A,Maggi M,Jannini EA
Published January 25, 2023Journal of endocrinological investigation
An Italian guideline from eleven medical societies finds that erectile dysfunction has many risk factors and calls for checking both partners. The panel graded its advice. It suggests looking for erectile dysfunction when a couple is checked for infertility. The guideline names PDE5 inhibitor pills as first-line treatment, after or with lifestyle change.
Key Findings
The guideline strongly recommends investigating erectile dysfunction in men with arterial hypertension, obesity, diabetes mellitus, or dyslipidemia.
Among men in infertile couples, sexual dysfunctions ranged from 6.7 to 75%, and erectile dysfunction affected about one in six infertile men.
A SIAMS survey reported erectile dysfunction in 56.2% of men undergoing assisted reproduction techniques (ART).
In one 2-year trial of men with metabolic syndrome and erectile dysfunction, more men on a Mediterranean diet regained erectile function than controls (37% vs 7%; p = 0.015).
The panel recommends against the term "psychogenic" for non-organic erectile dysfunction (expert opinion) and against diagnosing erectile dysfunction by exclusion (good clinical practice).
Interpretation
The guideline is a consensus document from an expert task force. Most recommendations carry a GRADE or practice-based label. Many rest on observational associations, while some lifestyle advice cites randomized trials. The authors say few studies checked erectile dysfunction in infertile couples with validated tools. Studies of men over 70 and under 40 are limited. The methods describe expert discussion of the best evidence available in PubMed.
RRM Context
Restorative reproductive medicine looks for the cause of infertility in both partners. The guideline adds male-side detail. Its authors say erectile dysfunction may also signal hypogonadism and poor general health in infertile men. They call for assessing the couple as a whole, which matches the restorative goal of evaluating both partners first.
Our editorial summary of this paper, not the article's abstract.
Abstract
Purpose
Erectile dysfunction (ED) is one of the most prevalent male sexual dysfunctions. ED has been in the past mistakenly considered a purely psycho-sexological symptom by patients and doctors. However, an ever-growing body of evidence supporting the role of several organic factors in the pathophysiological mechanisms underlying ED has been recognized.
Methods
The Italian Society of Andrology and Sexual Medicine (SIAMS) commissioned an expert task force involving several other National Societies to provide an updated guideline on the diagnosis and management of ED. Derived recommendations were based on the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.
Results
Several evidence-based statements were released providing the necessary up-to-date guidance in the context of ED with organic and psychosexual comorbidities. Many of them were related to incorrect lifestyle habits suggesting how to associate pharmacotherapies and counseling, in a couple-centered approach. Having the oral therapy with phosphodiesterase type 5 inhibitors as the gold standard along with several other medical and surgical therapies, new therapeutic or controversial options were also discussed.
Conclusions
These are the first guidelines based on a multidisciplinary approach that involves the most important Societies related to the field of sexual medicine. This fruitful discussion allowed for a general agreement on several recommendations and suggestions to be reached, which can support all stakeholders in improving couple sexual satisfaction and overall general health.
Mazzilli R et al., 2026·Journal of endocrinological investigation
Male factor could contribute, alone or in combination with female factor, to the inability to conceive in a couple in more than half of cases. The effect of male factor infertility (MFI) on embryological assisted reproductive technology (ART) outcomes remains an ongoing discussion.
to evaluate the impact of MFI on embryo aneuploidy rates, to better understand the role and possible indication for Preimplantation genetic testing for aneuploidies (PGT-A), considering the role of sperm characteristics, paternal age, sperm DNA fragmentation and sperm aneuploidies.
this narrative review included all available articles, published up to January 2026.
Available evidence, often based on heterogeneous and old-fashioned methodologies, suggests that MFI may impair embryonic development, particularly in terms of fertilization rate and blastulation rate, more than embryo euploidy; however, a comprehensive evaluation of MFI should be integrated into clinical practice in the context of couple infertility, to also optimize the efficiency and outcomes of ART. Promising results emerged from sperm DNA fragmentation as a tool to predict embryo euploidy, but further investigations involving larger sample sizes and improved standardization are required.
Besides gonadal involvement (hypogonadism, male factor infertility, and testicular hypotrophy), patients with Klinefelter syndrome (KS) may suffer from several extra-gonadic complications, including neoplastic events.
The aim of this review is to summarize all major clinical evidence dealing with the association between KS and neoplastic diseases and provide practical suggestions for the management of patients with KS regarding neoplastic risk.
This narrative review was conducted through a comprehensive search of the PubMed database, using combinations of the following keywords: "Klinefelter syndrome," "cancer," "neoplasm," "breast cancer," "germ cell tumor," "lymphoma," and "testosterone replacement therapy".
KS is associated with a higher risk of breast cancer and mediastinal germ cell tumors and an apparent higher risk of hematological malignancies, in particular non-Hodgkin lymphoma and leukemia. Evidence on testicular cancer is limited, with no clear increase in risk attributable to KS, while prostate cancer has a lower risk and lower mortality rate.
Given the complexity of the syndrome and the limited available evidence, regular clinical follow-up with targeted investigations when clinically indicated may facilitate early diagnosis and management of associated comorbidities.
Scala A et al., 2026·Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·Free full text on PubMed Central
In transgender adults, reference-gender choice alters Z-scores and fracture-risk estimates. Z-scores differ by 0.4-0.6 SD, with male references identifying more individuals with low BMD for age, especially in those assigned male at birth. Dual-reference reporting is advisable until further evidence becomes available.
Transgender individuals, especially those assigned male at birth (AMAB), exhibit lower bone mineral density (BMD) compared with the cisgender population. Interpretation of densitometric data is challenging, as the choice of reference gender can significantly influence Z-scores and fracture risk scores. This study aims to evaluate the impact of the gender reference database (male or female) on the assessment of BMD and fracture risk in transgender adults prior to gender-affirming hormone therapy (GAHT).
We conducted a cross-sectional analysis of 249 transgender individuals (153 assigned female at birth - AFAB and 96 AMAB) aged 18-43 years, recruited in the Hospitals of Padua and Brescia (Italy). Z-scores were calculated using both male and female reference databases and FRAX scores were computed using both gender inputs. Associations with anthropometric, biochemical, and hormonal parameters were explored.
Z-scores differed systematically depending on the reference gender, with mean ΔZ ranging 0.4-0.6 SD across skeletal sites. Switching reference databases frequently led to reclassification of BMD status. AMAB individuals showed a higher prevalence of low BMD for age, particularly when assessed against male references (27.1%), whereas AFAB participants generally maintained normal BMD. However, FRAX scores remained low. BMI and 25-OH vitamin D levels were independent predictors of BMD and Z-scores in AMAB individuals.
The choice of reference gender significantly influences densitometric interpretation in young transgender adults. Until further evidence becomes available, calculating Z-scores using both male and female reference databases is advisable. Early preventive interventions remain essential to preserve bone health.
De Toni L et al., 2026·Journal of endocrinological investigation·Free full text on PubMed Central
Varicocele is a recognized male factor of infertility. Surgical/microsurgical correction represents a therapeutical option to improve fertility outcomes but predictive parameters for the identification who can actually benefit from varicocele correction are under investigated. Here we aimed to identify baseline predictors of semen outcome improvement after varicocele treatment by scleroembolization approach.
85 patients receiving varicocele treatment by anterograde scleroembolization (ASE, N = 42) or retrograde scleroembolization (RSE, N = 43) were retrospectively recruited. Basal and 6-months follow-up evaluation of semen, hormonal and ultrasound parameters (US) were performed to address the respective effect of varicocele treatment. In addition, basal parameters were assessed as clinical outcome predictors.
Varicocele grade reduction was observed in more than 90% of patients (P < 0.001). Compared to basal, significant increase of sperm concentration (10.0 ± 9.2 × 106cells/mL vs. 23.4 ± 26.9 × 106cells/mL; P < 0.001), total sperm count (TSC 39.0 ± 54.5 × 106cells vs. 70.3 ± 90.6 × 106cells, P < 0.001) and total motile sperm count (TMS, 9.8 ± 12.8 × 106cells vs. 36.7 ± 58.1 × 106cells, P < 0.001), was observed, with no differences between RSE or ASE. All US parameters were also improved (all P < 0.001). Logistic regression analysis of basal semen and ultrasound parameters showed that basal sperm motility and left testis-mean transit time (L-MTT) were associated with TSC and TMS doubling at follow-up. However, Receiver Operating Characteristic curve analysis showed that only basal L-MTT basal sperm was consistently associated with TSC and TMS doubling at follow-up (respectively: AUC = 0.834, CI: 0.747-0.921 and AUC = 0.805, CI: 0.708-0.901; both P < 0.001).
Baseline sperm count and US parameters represent useful clinical descriptors to address those subjects eligible for varicocele correction.
Related research
Guidelines by Clinical Area · Bone and Endocrine Guidelines
Isidori AM et al., 2022·Journal of endocrinological investigation·Free full text on PubMed Central
To provide the evidence-based recommendations on the role of testosterone (T) on age-related symptoms and signs remains.
The Italian Society of Andrology and Sexual Medicine (SIAMS) and the and the Italian Society of Endocrinology (SIE) commissioned an expert task force to provide an updated guideline on adult-onset male hypogonadism. Derived recommendations were based on Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.
Clinical diagnosis of adult-onset hypogonadism should be based on a combination of clinical and biochemical parameters. Testosterone replacement therapy (TRT) should be offered to all symptomatic subjects with hypogonadism after the exclusion of possible contraindications. T gels and the long-acting injectable T are currently available preparations showing the best efficacy/safety profile. TRT can improve all aspects of sexual function, although its effect is limited in more complicated patients. Body composition (reducing fat mass and increasing lean mass) is improved after TRT, either in subjects with or without metabolic syndrome or type 2 diabetes. Conversely, the role of TRT in improving glycometabolic control is more conflicting. TRT can result in increasing bone mineral density, particularly at lumbar site, but no information on fracture risk is available. Limited data support the use of TRT for improving other outcomes, including mood frailty and mobility.
TRT can improve sexual function and body composition particularly in less complicated adult and in aging subjects with hypogonadism. When hypogonadism is adequately diagnosed, T appropriately prescribed and subjects correctly followed up, no short-term increased risk of adverse events is observed. Longer and larger studies are advisable to better clarify TRT long-term efficacy/safety profile.
Guidelines by Clinical Area · Bone and Endocrine Guidelines
Isidori AM et al., 2015·Journal of endocrinological investigation·Free full text on PubMed Central
We developed clinical practice guidelines to assess the individual risk-benefit profile of androgen replacement therapy in adult male hypogonadism (HG), defined by the presence of specific signs and symptoms and serum testosterone (T) below 12 nmol/L.
The task force consisted of eight clinicians experienced in treating HG, selected by the Italian Society of Endocrinology (SIE). The authors received no corporate funding or remuneration.
Consensus was guided by a systematic review of controlled trials conducted on men with a mean T < 12 nmol/L and by interactive discussions. The guidelines were reviewed and sequentially approved by the SIE Guidelines Commission and Executive Committee.
We recommend T supplementation (TS) for adult men with severely reduced T levels (T < 8 nmol/L) to improve body composition and sexual function. We suggest that TS be offered to subjects with T < 12 nmol/L to improve glycaemic control, lipid profile, sexual function, bone mineral density, muscle mass and depressive symptoms, once major contraindications have been ruled out. We suggest that lifestyle changes and other available interventions (e.g. for erectile dysfunction) be suggested prior to TS. We suggest that TS should be combined with currently available treatments for individuals at high risk for complications, such as those with osteoporosis and/or metabolic disorders. We recommend against using TS to improve cardiac outcome and limited mobility. We recommend against using TS in men with prostate cancer, unstable cardiovascular conditions or elevated haematocrit. The task force places a high value on the timely treatment of younger and middle-aged subjects to prevent the long-term consequences of hypoandrogenism.
Guidelines by Issuing Body · Specialty and Consensus Panels
Kim NN et al., 2025·Sexual medicine reviews·Free to read
Sexual function is a critical issue for human health and impacts the quality of life of patients and their partners. In this ICSM report, basic science and translational perspectives have been examined from the past decade of literature since the last ICSM report, and have been integrated to produce a state of the art summary of the physiology and molecular biology of sexual function/dysfunction and development of novel nanotechnology-based vehicles and treatments to aid regeneration and clinical translation in men and women.
Examine, critically assess, and curate the most important and impactful basic and translational research findings on male and female sexual dysfunction since 2015.
Literature reviews were performed by a multidisciplinary committee of sexual medicine experts between June 2023 through May 2024. Findings were presented at the ICSM meeting in Madrid (June 2024), and comments from the consultation were incorporated to develop this consensus report.
Erectile dysfunction (ED), which accompanies prostatectomy, diabetes, aging, and vascular disease in men, develops through both common and distinct mechanisms that involve neural injury, penile remodeling (smooth muscle (SM) apoptosis and increased collagen/fibrosis), dysregulated SM contractility, increased oxidative stress, immune response, and genomic instability. In women, disorders of genital pain, arousal, sexual desire, and orgasm involve multiple, overlapping neurological and endocrine mechanisms. Research on ED has been more extensive and the underlying molecular mechanisms have been better characterized than female sexual dysfunction. Future research directions should focus on pathways that underlie penile tissue remodeling and fibrosis associated with cavernous nerve injury in prostatectomy and diabetes, since this leads to irreversible ED. Particular emphasis should be placed on therapeutic targets to improve/enhance nerve regeneration, neuroprotection, "on demand" sexual function, SM contractility/relaxation, oxidative stress, immune response, and hormone function. In women, despite the existence of approved and off-label treatments for disorders of sexual desire and orgasm, the greater influence of psychosocial factors for these aspects of sexual function demands a multidisciplinary approach, along with predictive animal models. Genome-wide association studies have great potential in advancing the field but require replication and functional validation of findings from bioinformatic analyses. Progress in nanotechnology and regenerative therapies offers an exciting frontier in the targeted delivery of ameliorative/restorative treatments.
Research in sexual medicine has expanded through accelerated rates of discovery and increased breadth and diversity. However, much work remains in translating preclinical findings into biomarkers and clinical therapies that can improve patient outcomes.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Knowledge about Klinefelter syndrome (KS) has increased substantially since its first description almost 80 years ago. A variety of treatment options concerning the spectrum of symptoms associated with KS exists, also regarding aspects beyond testicular dysfunction. Nevertheless, the diagnostic rate is still low in relation to prevalence and no international guidelines are available for KS.
To create the first European Academy of Andrology (EAA) guidelines on KS.
An expert group of academicians appointed by the EAA generated a consensus guideline according to the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system.
Clinical features are highly variable among patients with KS, although common characteristics are severely attenuated spermatogenesis and Leydig cell impairment, resulting in azoospermia and hypergonadotropic hypogonadism. In addition, various manifestations of neurocognitive and psychosocial phenotypes have been described as well as an increased prevalence of adverse cardiovascular, metabolic and bone-related conditions which might explain the increased morbidity/mortality in KS. Moreover, compared to the general male population, a higher prevalence of dental, coagulation and autoimmune disorders is likely to exist in patients with KS. Both genetic and epigenetic effects due to the supernumerary X chromosome as well as testosterone deficiency contribute to this pathological pattern. The majority of patients with KS is diagnosed during adulthood, but symptoms can already become obvious during infancy, childhood or adolescence. The paediatric and juvenile patients with KS require specific attention regarding their development and fertility.
These guidelines provide recommendations and suggestions to care for patients with KS in various developmental stages ranging from childhood and adolescence to adulthood. This advice is based on recent research data and respective evaluations as well as validations performed by a group of experts.
Clinical Guidelines and Standards › Guidelines by Clinical Area › Bone and Endocrine Guidelines
G Di Lorenzo
PMID 36698034 36698034 DOI 10.1007/s40618-023-02015-5 10.1007/s40618-023-02015-5 Corona et al. 2023, Corona 2023
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