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Completed

NCT Number: NCT02788136

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

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

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Key information

Conditions

Steroidogenesis Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Human Chorionic Gonadotropin (hCG) Stimulation Hypogonadism Klinefelter Syndrome Male Urogenital Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

AziendaUSLModena

Modena, 41126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Chorionic Gonadotropin

Drug

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

Other names: hCG

Primary outcomes

  1. Testosterone

    Time frame: visit 1 (Day 1)

    Using mass spectrometry

Secondary outcomes

  1. Testicular volume

    Time frame: visit 0 (Baseline)

    testicular volume at ultrasonography

  2. Steroids

    Time frame: Visit 0 (Baseline)

    Steroidogenesis evaluated through mass spectrometry

  3. Steroids

    Time frame: Visit 1 (Day 1)

    Steroidogenesis evaluated through mass spectrometry

  4. Steroids

    Time frame: Visit 2 (Day 2)

    Steroidogenesis evaluated through mass spectrometry

  5. Steroids

    Time frame: Visit 3 (Day 3)

    Steroidogenesis evaluated through mass spectrometry

  6. Steroids

    Time frame: Visit 4 (Day 4)

    Steroidogenesis evaluated through mass spectrometry

  7. Steroids

    Time frame: Visit 5 (Day 5)

    Steroidogenesis evaluated through mass spectrometry

Sponsors and collaborators

Lead sponsor

Azienda USL Modena

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 2, 2016
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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