An open-label clinical trial to investigate the efficacy and safety of corifollitropin alfa combined with hCG in adult men with hypogonadotropic hypogonadism

What Was Tested

This clinical trial, phase iii paper looks at hCG (human chorionic gonadotropin).

Hypogonadotropic hypogonadism (HH) in men results in insufficient testicular function and deficiencies in testosterone and spermatogenesis.

Combinations of human chorionic gonadotropin (hCG) and recombinant follicle-stimulating hormone (recFSH) have been successful in the treatment of HH.

Who Took Part

According to the abstract, 23 subjects were involved.

By PubMed's age tags, the people studied were young adults, adults and middle-aged adults, men only.

This was a Phase III, multi-center, open-label, single-arm trial of corifollitropin alfa in azoospermic men aged 18 to 50 years with HH.

How the Study Was Run

The researchers set it up as a open-label study.

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

Safety was evaluated by the presence of anti-corifollitropin alfa antibodies and the occurrence of adverse events (AEs).

What Was Measured

Hypogonadotropic hypogonadism (HH) in men results in insufficient testicular function and deficiencies in testosterone and spermatogenesis.

Topics PubMed links to this paper include Azoospermia, Chorionic Gonadotropin, Follicle Stimulating Hormone, Human, Hypogonadism, Organ Size, Spermatogenesis and Testis.

The authors tagged it with the keywords Corifollitropin alfa, Gonadotropin deficiency, Hypogonadotropic hypogonadism and Male infertility.

What This Means in Plain Language

The paper is an open-label study of hCG (human chorionic gonadotropin) in 23 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2017 (Reproductive biology and endocrinology : RB&E), a journal based in England.

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