Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH)

What Was Tested

This registered phase 4 trial tested hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin).

One third of the participants will receive hCG treatment alone and the other third of the participants will receive hCG treatment alone for six months, then the hMG will be added.

And the last third of the participants will receive hCG and hMG treatment since the beginning of the treatment.

It had three arms (groups): Human Chorionic Gonadotropin alone (active comparator), hCG alone for 6 months then hMG added (experimental) and hCG and hMG (experimental).

The registry classes the interventions as drug.

More on the Plan

However, these studies were mostly non-randomized controlled studies with small size of samples and short follow-up time.

In different reported studies, the hCG plus hMG treatment had two regimens: using hCG alone for six month, then hMG was added and using hCG plus hMG since the beginning of the treatment.

Who Took Part

210 planned participants were the target.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Age ≥ 18, ≤ 45 years old;. Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner score ﹤ 5;. Other pituitary hormone levels are normal;. Head MRI examination is normal;. Fertility is desired currently or will be desired in the future;.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: primary hypogonadism;; acquired hypogonadotrophic hypogonadism;; A history of treatment with pulsed GnRH, hCG and FSH related hormones;.

How the Study Was Run

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

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

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 2018-10-18 with completion listed for 2024-10-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Sperm density (time frame: 6 months).

It also tracked 8 secondary outcomes, for example Semen volume, Sperm activity, The time for sperm to appear during treatment, Serum testosterone levels, Testicular volume and Penis length.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin) in 210 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.