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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Steroidogenesis, Klinefelter Syndrome, Human Chorionic Gonadotropin (hCG) Stimulation

Intervention / Treatment
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* Drug: human chorionic gonadotropin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Klinefelter syndrome<br>13 men with diagnosis of Klinefelter syndrome were stimulated with human chorionic gonadotropin (hCG) | Drug: human chorionic gonadotropin<br>* At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU<br>* Other names: hCG;|
| Active Comparator: Control<br>12 healthy age-related men were stimulated with human chorionic gonadotropin (hCG) | Drug: human chorionic gonadotropin<br>* At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU<br>* Other names: hCG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone | Using mass spectrometry | visit 1 (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testicular volume | testicular volume at ultrasonography | visit 0 (Baseline) | 
| Steroids | Steroidogenesis evaluated through mass spectrometry | Visit 0 (Baseline) | 
| Steroids | Steroidogenesis evaluated through mass spectrometry | Visit 1 (Day 1) | 
| Steroids | Steroidogenesis evaluated through mass spectrometry | Visit 2 (Day 2) | 
| Steroids | Steroidogenesis evaluated through mass spectrometry | Visit 3 (Day 3) | 
| Steroids | Steroidogenesis evaluated through mass spectrometry | Visit 4 (Day 4) | 
| Steroids | Steroidogenesis evaluated through mass spectrometry | Visit 5 (Day 5) |