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The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional | Active Comparator |
| |
| Sequential | Experimental |
| |
| Sequential Plus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional intervention for HH using HCG and FSH | Drug | Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year; |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm density ≥1,000,000/ml | The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject. | One and a half year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao-Ying Li, MD,PhD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25825944 | Derived | Zhang M, Tong G, Liu Y, Mu Y, Weng J, Xue Y, Luo Z, Xue Y, Shi L, Wu X, Sun S, Zhu Y, Cao Y, Zhang J, Huang H, Niu B, Li H, Guo Q, Gao Y, Li Z, Ning G, Zhu D, Li X; HHIS Study Group. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism. J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31. |
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|
| Sequential intervention for HH using HCG and FSH | Drug | Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months |
|
|
| Sequential intervention for HH using HCG and FSH plus zinc | Drug | Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily |
|
|
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D017436 | Kallmann Syndrome |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D058490 | Disorder of Sex Development, 46,XY |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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