Klinefelter Syndrome Clinical Trial
Official title:
Androgen Treatment in Leydig Cell Proliferation
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.
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.
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