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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02788136
Enrollment
25
Registered
2016-06-02
Start date
2012-02-29
Completion date
2014-07-31
Last updated
2016-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 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.

Interventions

DRUGhuman chorionic gonadotropin

At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU

Sponsors

Azienda USL Modena
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Testosteronevisit 1 (Day 1)Using mass spectrometry

Secondary

MeasureTime frameDescription
Testicular volumevisit 0 (Baseline)testicular volume at ultrasonography
SteroidsVisit 0 (Baseline)Steroidogenesis evaluated through mass spectrometry

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026