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

Klinefelter Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788136
• Other study ID #: Klinefelter & hCG
• Status: Completed
• Phase: N/A
• First received: May 30, 2016
• Last updated: June 6, 2016
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: June 2016
• Source: Azienda USL Modena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana del Farmaco (AIFA)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Drug:
• human chorionic gonadotropin
At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU

Locations

Country	Name	City	State
Italy	AziendaUSLModena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Modena

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Belli S, Santi D, Leoni E, Dall'Olio E, Fanelli F, Mezzullo M, Pelusi C, Roli L, Tagliavini S, Trenti T, Granata AR, Pagotto U, Pasquali R, Rochira V, Carani C, Simoni M. Human chorionic gonadotropin stimulation gives evidence of differences in testicular steroidogenesis in Klinefelter syndrome, as assessed by liquid chromatography-tandem mass spectrometry. Eur J Endocrinol. 2016 Jun;174(6):801-11. doi: 10.1530/EJE-15-1224. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosterone	Using mass spectrometry	visit 1 (Day 1)	Yes
Secondary	Testicular volume	testicular volume at ultrasonography	visit 0 (Baseline)	No
Secondary	Steroids	Steroidogenesis evaluated through mass spectrometry	Visit 0 (Baseline)	Yes
Secondary	Steroids	Steroidogenesis evaluated through mass spectrometry	Visit 1 (Day 1)	Yes
Secondary	Steroids	Steroidogenesis evaluated through mass spectrometry	Visit 2 (Day 2)	Yes
Secondary	Steroids	Steroidogenesis evaluated through mass spectrometry	Visit 3 (Day 3)	Yes
Secondary	Steroids	Steroidogenesis evaluated through mass spectrometry	Visit 4 (Day 4)	Yes
Secondary	Steroids	Steroidogenesis evaluated through mass spectrometry	Visit 5 (Day 5)	Yes