Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH) (IHH)
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- STATUS
- Recruiting
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- End date
- Oct 1, 2025
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- participants needed
- 210
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- sponsor
- Tongji Hospital
Summary
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.
Description
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.
Details
| Condition | Isolated Hypogonadotropic Hypogonadism, Kallmann Syndrome, Infertility |
|---|---|
| Treatment | human menopausal gonadotropin, Human Chorionic Gonadotropin |
| Clinical Study Identifier | NCT03687606 |
| Sponsor | Tongji Hospital |
| Last Modified on | 4 March 2022 |
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