Clinical Trials Logo

Clinical Trial Summary

Patients with infertility often presents alterations at ultrasonographic examination of the testis. These alterations include a much higher incidence of small, multiple, non-palpable hypoechoic micro-nodules that can show internal vascularization. This finding often create alarm and anxiety, because it has to be placed in a differential diagnosis versus low-stage malignant germ cell tumors. Nevertheless, explorative surgery reveal that a consistent number of these lesion are benign, due to Leydig cell hyperplasia or Leydig cell tumours. The purpose of this study is to evaluate the effects of androgen therapy on the size and number of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin levels.


Clinical Trial Description

Patients with the testicular dysgenesis syndrome, that comprises a variable spectrum of clinical manifestations, such as infertility, cryptorchidism, hypospadias, impaired spermatogenesis and testicular germ cell neoplasms, often develop alterations in the Leydig cell compartment. These alterations range from abnormal localization and clustering to hyperplasia or tumorous formation.

Leydig cell tumors (LCTs), although uncommon in the general population, are the most frequent non-germ cell testicular neoplasms, and their incidence has been reported increasingly growing, especially in infertile patients. Given that the focal areas of Leydig cell hyperplasia are nowadays easily detectable at ultrasonography of the testis (US), as small non-palpable hypoechoic micro-nodules that can show internal vascularization, their finding create a diagnostic challenge versus low-stage malignant germ cell tumors.

Patients with testicular dysgenesis syndrome in general exhibit an elevation of Follicle-Stimulating Hormone (FSH), but in these patients, very frequently, even Luteinizing Hormone (LH) is above the reference range. The latter can work as a growth factor for Leydig cells. Since exogenous testosterone can suppress LH levels, it could be that androgen therapy could revert the LH-induced growth stimulation of Leydig cell compartment.

The purpose of this study is to evaluate the effects of androgen therapy on the size and number of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin levels.

The purpose of this study is also to evaluate whether the behavior (UltraSonographic appearance, US) of the non-palpable hypoechoic micro-nodules during a 4-month trial of testosterone therapy can offer a novel diagnostic tool in the differential diagnosis of benign versus malignant testicular nodules.

The trial will be open only for patients with multiple non-palpable hypoechoic micro-nodules that have an elevation of both FSH and LH and that are not seeking conception.

Participants in the study will be randomized to one of two treatment groups, receiving either testosterone undecanoate (low-dose androgen) or placebo, for two 6 months. All participants will be evaluated for safety at the beginning of the study and at 2, 4, and 6 months with careful history, physical examination, blood sampling and testicular ultrasonography. Patients will also be offered the possibility to perform Magnetic Resonance Imaging (MRI) of the testis at baseline and after treatment, and/or surgical enucleation of the lesions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01206270
Study type Interventional
Source University of Roma La Sapienza
Contact
Status Completed
Phase Phase 2/Phase 3
Start date June 2009
Completion date June 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03396562 - The eXtroardinarY Babies Study: Natural History of Health and Neurodevelopment in Infants and Young Children With Sex Chromosome Trisomy
Completed NCT02526628 - Thrombosis and Neurocognition in Klinefelter Syndrome
Completed NCT01690013 - Life Quality and Health in Patients With Klinefelter Syndrome N/A
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Completed NCT01918280 - Fertility Preservation in Cases of Klinefelter Syndrome. N/A
Completed NCT02787486 - Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Completed NCT03325647 - TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY Phase 4
Enrolling by invitation NCT03836300 - Parent and Infant Inter(X)Action Intervention (PIXI) N/A
Recruiting NCT05498090 - Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males With Klinefelter Syndrome Phase 4
Completed NCT00999310 - Neuropsychologic, Neuroradiologic, Endocrinologic, and Genetic Aspects of Klinefelter Syndrome N/A
Completed NCT02408445 - Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment Phase 4
Completed NCT00896272 - Adaptation Among Adolescents and Adults With Klinefelter Syndrome
Completed NCT02723305 - Cardiometabolic Profiles of Boys With Klinefelter Syndrome
Completed NCT05581147 - Thyroid Function and Structure IN Klinefelter Syndrome
Recruiting NCT05586802 - Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome Phase 3
Active, not recruiting NCT02430584 - Whole Blood Specimen Collection From Pregnant Subjects
Completed NCT01817296 - Klinefelter Fertility Preservation N/A
Completed NCT01585831 - Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome N/A
Withdrawn NCT00347464 - Adaptive Behavior Assessment of Men With 49, XXXXY, Klinefelter Syndrome N/A
Recruiting NCT05425953 - Endocrine, Metabolic, Cardiovascular and Immunological Aspects of Sex Chromosome Abnormalities in Relation to Genotype