Clinical Trial: Human Chorionic Gonadotropin Stimulation Effects on Steroidogenesis in Men With Klinefelter Syndrome

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

Official Title: Analisi Del Profilo Sierico Steroideo Basale e Dopo Stimolo Con Gonadotropina Corionica Umana (HCG) Nei Soggetti Affetti da Sindrome di Klinefelter (SK).

Brief Summary: The study design included six visits. During the first visit (visit 0), the subjects underwent physical examination(height, weight, body mass index (BMI), arm span, and upper segment measurement) and testicular ultrasound (US) for the calculation of testicular volume. At 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a single intramuscular injection of hCG of 5000 IU. Further five visits were performed each of five following consecutive days after the hCG injection. A blood sample was taken at each visit after an overnight fast

Detailed Summary: Blood samples were centrifuged at 2955 g for 15 min. Sera were transferred into plain polypropylene tubes and stored at −20°C until assayed. P, 17OHP, AS, DHEA, and TS were determined by LC-MS/MS at the laboratory of the Centre for Applied Biomedical Research of the S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
Sponsor: Azienda USL Modena

Current Primary Outcome: Testosterone [ Time Frame: visit 1 (Day 1) ]

Using mass spectrometry


Original Primary Outcome:

  • Steroids [ Time Frame: visit 0 ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: visit 1 ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: visit 2 ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: vist 3 ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: visit 4 ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: visit 5 ]
    Steroidogenesis evaluated through mass spectrometry


Current Secondary Outcome:

  • Testicular volume [ Time Frame: visit 0 (Baseline) ]
    testicular volume at ultrasonography
  • Steroids [ Time Frame: Visit 0 (Baseline) ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: Visit 1 (Day 1) ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: Visit 2 (Day 2) ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: Visit 3 (Day 3) ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: Visit 4 (Day 4) ]
    Steroidogenesis evaluated through mass spectrometry
  • Steroids [ Time Frame: Visit 5 (Day 5) ]
    Steroidogenesis evaluated through mass spectrometry


Original Secondary Outcome: Testicular volume [ Time Frame: visit 0 ]

testicular volume at ultrasonography


Information By: Azienda USL Modena

Dates:
Date Received: May 30, 2016
Date Started: February 2012
Date Completion:
Last Updated: June 6, 2016
Last Verified: June 2016