Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome

What Was Tested

This registered not phased trial tested Gonadorelin.

To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.

It had 1 arm (groups): treatment group (experimental).

The registry classes the interventions as drug.

More on the Plan

The hormonal response of the hypothalamic-pituitary-gonad axis was assessed after pulsatile GnRH replacement by measurement of serum T, LH and FSH.

A standard seminal fluid analysis was performed in men who could produce an ejaculate.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18 years or over male patients;. Absent or incomplete puberty development;. At least two or more pituitary hormone deficiencies.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: cryptorchidism history; other causes of hypopituitarism or severe systemic disease.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Gonadorelin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-01 with completion listed for 2016-08.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change of serum Luteinizing Hormone(LH) value (time frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment). Change of serum Follicle-Stimulating Hormone (FSH) value (time frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment). Change of serum total testosterone value (time frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment).

It also tracked 3 secondary outcomes, for example Change of testicular volume, Change of sperm counts by routine semen analysis and the rate of impregnating subject's wife.

What This Means in Plain Language

Put simply, this is a not phased trial of Gonadorelin in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Gonadorelin compound page, all human trials.