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

What Was Tested

This registered not phased trial tested hCG (human chorionic gonadotropin).

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.

It had two arms (groups): Klinefelter syndrome (experimental) and Control (active comparator).

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

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

The registry classes the interventions as drug.

More on the Plan

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 Took Part

The registry lists 25 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Klinefelter syndrome diagnosis at kariotype evaluation for the study group. Healthy age-matched men in the control group.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: previous or ongoing androgen therapy.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-02 with completion listed for 2014-07.

It ran at 1 site in Italy.

What Was Measured

Primary outcome: Testosterone (time frame: visit 1 (Day 1)).

It also tracked 7 secondary outcomes, for example Testicular volume, Steroids, Steroids, Steroids, Steroids and Steroids.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of hCG (human chorionic gonadotropin) in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.