Hypogonadotropic Hypogonadism, Kallmann Syndrome
Conditions
Keywords
Hypogonadotropic Hypogonadism, Kallmann Syndrome, LH, FSH
Brief summary
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.
Interventions
DRUGTraditional intervention for HH using HCG and FSH
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;
DRUGSequential intervention for HH using HCG and FSH
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
DRUGSequential intervention for HH using HCG and FSH plus zinc
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
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Clinical hypogonadotropic hypogonadism * Hormonal levels: Testosterone \< 1.8ng/ml, LH \< 2-3 mIU/mL and FSH \< 2-3 mIU/mL * Infantile testis * Delayed bone age * Normal testing of the anterior pituitary gland
Exclusion criteria
* Prior therapy with HMG or FSH * Severe dysfunction of live and kidney * Cryptorchidism or no response to HCG stimulation experiment (Testosterone \< 1.8ng/ml after HCG stimulation) * Another pituitary hormonal deficiency * Hypergonadotropic hypogonadism * With abnormal karyotype
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm density ≥1,000,000/ml | One and a half year | The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject. |
Countries
China
Outcome results
None listed