Isolated Hypogonadotropic Hypogonadism, Kallmann Syndrome, Infertility
Conditions
Keywords
Gonadotropin treatment, human chorionic gonadotropin, human menopausal gonadotropin
Brief 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.
Detailed 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.
Interventions
DRUGHuman Chorionic Gonadotropin
White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.
White freeze-dried cake or powder with specification of 75IU.
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18, ≤ 45 years old; 2. Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner score ﹤ 5; 3. Serum FSH and LH levels are low or in normal low value, testosterone was lower than normal range (1.75ng / ml, the lower limit of the normal blood testosterone reference range of Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology); 4. With or without olfactory loss/reduction; 5. Other pituitary hormone levels are normal; 6. Head MRI examination is normal; 7. Fertility is desired currently or will be desired in the future; 8. Understand and sign the informed consent form.
Exclusion criteria
1. Primary hypogonadism; 2. Acquired hypogonadotrophic hypogonadism; 3. A history of treatment with pulsed GnRH, hCG and FSH related hormones; 4. Receive testosterone replacement therapy for more than 6 months; 5. History of cryptorchidism or cryptorchidism; 6. The sperm density before treatment ≥1×10\^6/ml; 7. Moderate or severe liver and kidney dysfunction (ALT\>120IU/L, AST\>80IU/L, CR\>115μmol/L); 8. The karyotype is 45,X or 47,XXY and 48, XXXY and other abnormal karyotypes; 9. True hermaphroditism and pseudohermaphroditism; 10. Sex hormone abnormalities caused by adrenal lesions; 11. Hypogonadism secondary to other systemic diseases; 12. Abnormal secretion of hormones caused by brain lesions (such as pituitary tumors); 13. There are other hormone abnormalities in the pituitary; 14. There are contraindications for the treatment with hCG or hMG.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm density | 6 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum testosterone levels | 3 months. | The serum testosterone levels will be tested in every visit. |
| Penis length | 3 months. | Penis length will be measured from the pubic symphysis to glans using a vernier caliper. |
| Pubic hair | 3 months. | Pubic hair will be evaluated according to Tanner pubertal stages. |
| Genitalia | 3 months. | Genitalia will be evaluated according to Tanner pubertal stages. |
| Semen volume | 6 months. | 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. |
| Sperm activity | 6 months. | 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. |
| The time for sperm to appear during treatment | 6 months. | The time for the sperm firstly appeared in the semen will be recorded. |
| Testicular volume | 3 months. | Testicular volume will be measured using a Prader orchidometer. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Height | 3 months. | Height will be measured at every visit. |
| Feeling of inferiority scale score | 3 months. | Feeling of inferiority scale scores will be obtained using feeling of inferiority scale. |
| Weight | 3 months. | Weight will be measured at every visit. |
Countries
China
Contacts
Primary ContactHao Xu, M.D
Backup ContactYinwei Chen, M.D
Outcome results
None listed