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

June 6, 2016 updated by: Manuela Simoni, Azienda USL Modena

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41126
        • AziendaUSLModena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • hCG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Modena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

May 30, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Klinefelter & hCG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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