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Trial record 20 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

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ClinicalTrials.gov Identifier: NCT02788136
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Manuela Simoni, Azienda USL Modena

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

Condition or disease Intervention/treatment Phase
Steroidogenesis Klinefelter Syndrome Human Chorionic Gonadotropin (hCG) Stimulation Drug: human chorionic gonadotropin Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Analisi Del Profilo Sierico Steroideo Basale e Dopo Stimolo Con Gonadotropina Corionica Umana (HCG) Nei Soggetti Affetti da Sindrome di Klinefelter (SK).
Study Start Date : February 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Klinefelter syndrome
13 men with diagnosis of Klinefelter syndrome were stimulated with human chorionic gonadotropin (hCG)
Drug: human chorionic gonadotropin
At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU
Other Name: hCG

Active Comparator: Control
12 healthy age-related men were stimulated with human chorionic gonadotropin (hCG)
Drug: human chorionic gonadotropin
At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU
Other Name: hCG




Primary Outcome Measures :
  1. Testosterone [ Time Frame: visit 1 (Day 1) ]
    Using mass spectrometry


Secondary Outcome Measures :
  1. Testicular volume [ Time Frame: visit 0 (Baseline) ]
    testicular volume at ultrasonography

  2. Steroids [ Time Frame: Visit 0 (Baseline) ]
    Steroidogenesis evaluated through mass spectrometry

  3. Steroids [ Time Frame: Visit 1 (Day 1) ]
    Steroidogenesis evaluated through mass spectrometry

  4. Steroids [ Time Frame: Visit 2 (Day 2) ]
    Steroidogenesis evaluated through mass spectrometry

  5. Steroids [ Time Frame: Visit 3 (Day 3) ]
    Steroidogenesis evaluated through mass spectrometry

  6. Steroids [ Time Frame: Visit 4 (Day 4) ]
    Steroidogenesis evaluated through mass spectrometry

  7. Steroids [ Time Frame: Visit 5 (Day 5) ]
    Steroidogenesis evaluated through mass spectrometry



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Klinefelter syndrome diagnosis at kariotype evaluation for the study group
  • Healthy age-matched men in the control group

Exclusion Criteria:

  • previous or ongoing androgen therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788136


Locations
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Italy
AziendaUSLModena
Modena, Italy, 41126
Sponsors and Collaborators
Azienda USL Modena

Publications:
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Responsible Party: Manuela Simoni, Ordinary Professor, Azienda USL Modena
ClinicalTrials.gov Identifier: NCT02788136     History of Changes
Other Study ID Numbers: Klinefelter & hCG
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Klinefelter Syndrome
Syndrome
Disease
Pathologic Processes
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism
Reproductive Control Agents
Physiological Effects of Drugs