Status:
COMPLETED
Androgen for Leydig Cell Proliferation
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Klinefelter Syndrome
Hypergonadotropic Hypogonadism
Eligibility:
MALE
18-60 years
Phase:
PHASE2
PHASE3
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-...
Detailed Description
Patients with the testicular dysgenesis syndrome, that comprises a variable spectrum of clinical manifestations, such as infertility, cryptorchidism, hypospadias, impaired spermatogenesis and testicul...
Eligibility Criteria
Inclusion
- Non-palpable Multiple hypoechoic testicular nodules (with the largest having a diameter \> 2 mm and \< 12 mm)
- Serum Follicle-stimulating hormone (FSH) \> 7 mIU/ml (m-International-Unit/ml)
- Serum Luteinizing hormone (LH) \> 7 IU (International-Unit/ml)
- Infertility: Klinefelter Syndrome, Hypergonadotropic Hypogonadism, Hypergonadotropic Azospermia, Hypergonadotropic Cryptozoospermia
- negative testicular tumors markers: beta-hCG (Human chorionic gonadotropin), alpha-FP (alpha-Feto-Protein), CEA (Carcinoembryonic antigen), LDH (Lactate dehydrogenase), ferritin, PLAP (Placental Alkaline Phosphatase).
Exclusion
- Hypogonadotropic Hypogonadism
- FSH o LH \< 7 UI
- non-homogeneous testicular lesion \> 12 mm
- positive testicular tumors markers: beta-hCG, alpha-FP, CEA, LDH, ferritin, PLAP
- patients with contraindication to testosterone therapy: prostate cancer, PSA\>4 ng/ml, severe hepatic or renal insufficiency, Hb\>17, Htc\>52%, severe urinary retention
- desire to conceive
- history of germ-cell testicular neoplasia
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01206270
Start Date
June 1 2009
End Date
June 1 2018
Last Update
September 25 2018
Active Locations (1)
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1
Dipartimento di Fisiopatologia Medica
Rome, Lazio, Italy, 00161