Sequential Therapy for Hypogonadotropic Hypogonadism

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin).

The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs.

Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable.

The zinc supplement will be also evaluated in patients in this study.

It had three arms (groups): Traditional (active comparator), Sequential (experimental) and Sequential Plus (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 100 actual participants took part.

It was open to men only aged from 16 years up to 45 years.

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

Examples of who could join: Clinical hypogonadotropic hypogonadism. Hormonal levels: Testosterone \< 1.8ng/ml, LH \< 2-3 mIU/mL and FSH \< 2-3 mIU/mL. Delayed bone age. Normal testing of the anterior pituitary gland.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: prior therapy with hmg or fsh; severe dysfunction of live and kidney; cryptorchidism or no response to hcg stimulation experiment (testosterone \< 1.8ng/ml after hcg stimulation).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2009-09 with completion listed for 2012-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Sperm density ≥1,000,000/ml (time frame: One and a half year).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 100 people.

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.