Clinical Trial: Androgen for Leydig Cell Proliferation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Androgen Treatment in Leydig Cell Proliferation

Brief 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.

Detailed Summary:

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 too
Sponsor: University of Roma La Sapienza

Current Primary Outcome: Nodule Size per Number [ Time Frame: 4 month ]

Percentage change of the area of the lesions multiplied by the number of the measured lesions: [(area_1 + area_2 + area_3 + ... + area_n)*n].

The latter measure account for reduction in the number of lesions (disappearence).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Nodule Size [ Time Frame: 4 month ]
    Percentage change in the area of the lesion (measured with computer assisted graphics).
  • Luteinizing Hormone (LH) [ Time Frame: 2 month ]
    Reduction of the serum Luteinizing Hormone (LH) levels during testosterone teraphy
  • Spermatogenesis [ Time Frame: 8 month (follow-up) ]
    Evaluation of sperm cell production after testosterone withdrawl.


Original Secondary Outcome: Same as current

Information By: University of Roma La Sapienza

Dates:
Date Received: September 9, 2010
Date Started: June 2009
Date Completion:
Last Updated: October 25, 2014
Last Verified: October 2014