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

NCT ID: NCT02788136

Last Updated: 2016-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-07-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Klinefelter syndrome

13 men with diagnosis of Klinefelter syndrome were stimulated with human chorionic gonadotropin (hCG)

Group Type: EXPERIMENTAL

human chorionic gonadotropin

Intervention Type: DRUG

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

Control

12 healthy age-related men were stimulated with human chorionic gonadotropin (hCG)

Group Type: ACTIVE_COMPARATOR

human chorionic gonadotropin

Intervention Type: DRUG

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

Interventions

human chorionic gonadotropin

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

Intervention Type: DRUG

Other Intervention Names

hCG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda USL Modena

OTHER

Sponsor Role: lead

Responsible Party

Manuela Simoni

Ordinary Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AziendaUSLModena

Modena, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 27188454 (View on PubMed)

Other Identifiers

Klinefelter & hCG

Identifier Type: -

Identifier Source: org_study_id