Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin Treat Congenital Hypogonadotropic Hypogonadism

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin).

It had two arms (groups): Human Menopausal Gonadotropin (experimental) and Human Chorionic Gonadotropin (experimental).

Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

Human chorionic gonadotropin (hCG) is a hormone produced by the embryo after implantation.

The registry classes the interventions as drug.

More on the Plan

Establish technological process and follow-up precept for human menopausal gonadotropin and human chorionic gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers.

Who Took Part

40 planned participants were the target.

It was open to men only aged from 138 months up to 18 years.

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

Examples of who could join: Sex hormone (LH,FSH, T) are pre-pubertal level. No other hormones problems (other pituitary glands axis are normal except gonad axis). No space occupying lesion, No tumor on MRI of pituitary and hypothalamus area. Kallmann's syndrome(KS) patients may companies with dysosmia or dysplasia of olfactory bulb or olfactory tract on MRI. Karyotype is 46，XY.

The full record lists 10 inclusion and 5 exclusion criteria; among the exclusions: any ascertain reason contributes to the non puberty development (chromosome abnormal, trauma, surgeries) or any ascertain disease such as prader-willi syndrome or hypergonadotropic hypogonadism; systemic diseases (such as chronic kidney failure, mediterranean anemia, poor controlled diabetes); protein-energy malnutrition.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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

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 2016-08 with completion listed for 2017-08.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): testicular volume (time frame: Change from Baseline testicular volume at 3 months after treatment).

It also tracked 1 secondary outcome, for example The levels of testosterone serum (It were measured with chemiluminescent immunoassay Elecsys).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin) in 40 people.

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

More context: the hCG (human chorionic gonadotropin) compound page and the HMG (Human Menopausal Gonadotropin) compound page, all human trials.