Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism

What Was Tested

This registered phase 4 trial tested hCG (human chorionic gonadotropin).

It had two arms (groups): Pulsatile Gonadotropin Releasing Hormone (experimental) and combination gonadotropin therapy (active comparator).

Pulsatile Gonadotropin Releasing Hormone: subjects in the GnRH group initiated a regimen of pulsatile GnRH administered subcutaneously via a portable infusion pump for 18 months.

Combined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months.

The registry classes the interventions as drug.

More on the Plan

The primary endpoint was the achievement of pregnancy in female partner.

Secondary endpoints were time to actual attainment of various sperm thresholds: sperm concentration\>0\*10\^6/ml , \>1.0 \*10\^6/ml and \>15 \*10\^6/ml, respectively.

Who Took Part

76 actual participants took part.

It was open to men only aged from 16 years up to 35 years.

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

Examples of who could join: Age greater than 16 yr. Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism. Hypogonadal serum testosterone levels (\<166ng/dl) in the presence of low or normal gonadotropins. Normal levels of other anterior pituitary hormones. Normal MRI scans of the hypothalamo-pituitary region.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: congenital hypopituitarism; any medical or surgical conditions possibly affecting the experiment result.

How the Study Was Run

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

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

It started in 2010-01 with completion listed for 2014-06.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: pregnancy in the female partner (time frame: 18 months).

It also tracked 3 secondary outcomes, for example first appearance of sperm (month after treatment), first time with sperm density>1*10^6/ml（month after treatment） and first time with sperm density>15*10^6/ml（month after treatment）.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of hCG (human chorionic gonadotropin) in 76 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, all human trials.