This study will evaluate the efficacy and safety of long term use of hCG alone or hCG plus hMG in the treatment of male patients with isolated hypogonadotropic hypogonadism (IHH). 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.
The efficacy of hCG alone or hCG plus hMG in the treatment of male IHH patients was reported in some studies. However, these studies were mostly non-randomized controlled studies with small size of samples and short follow-up time. There was also no reported study which aimed to compare the efficacy and safety of long term use of hCG or hCG plus hMG in the treatment of male patients with IHH. So the difference in the efficacy and safety between long term use of hCG alone and hCG plus hMG in the treatment of IHH is unknown. 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. The difference in the efficacy and safety between the above two regimes is also unknown.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.
White freeze-dried cake or powder with specification of 75IU.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGSperm density
Sperm density will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Time frame: 6 months.
Semen volume
Sperm volume will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Time frame: 6 months.
Sperm activity
Sperm activity will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Time frame: 6 months.
The time for sperm to appear during treatment
The time for the sperm firstly appeared in the semen will be recorded.
Time frame: 6 months.
Serum testosterone levels
The serum testosterone levels will be tested in every visit.
Time frame: 3 months.
Testicular volume
Testicular volume will be measured using a Prader orchidometer.
Time frame: 3 months.
Penis length
Penis length will be measured from the pubic symphysis to glans using a vernier caliper.
Time frame: 3 months.
Pubic hair
Pubic hair will be evaluated according to Tanner pubertal stages.
Time frame: 3 months.
Genitalia
Genitalia will be evaluated according to Tanner pubertal stages.
Time frame: 3 months.
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