Infertility Clinical Trial
— IHHOfficial title:
Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in the Treatment of Male Patients With Isolated Hypogonadotropic Hypogonadism: an Open, Randomized Controlled Study
Verified date | April 2020 |
Source | Tongji Hospital |
Contact | Hao Xu, M.D |
Phone | +86-15872427301 |
haoxutjmu[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
China,
Matsumoto AM, Snyder PJ, Bhasin S, Martin K, Weber T, Winters S, Spratt D, Brentzel J, O'Dea L. Stimulation of spermatogenesis with recombinant human follicle-stimulating hormone (follitropin alfa; GONAL-f): long-term treatment in azoospermic men with hypogonadotropic hypogonadism. Fertil Steril. 2009 Sep;92(3):979-90. doi: 10.1016/j.fertnstert.2008.07.1742. Epub 2008 Oct 18. — View Citation
Zacharin M, Sabin MA, Nair VV, Dabadghao P. Addition of recombinant follicle-stimulating hormone to human chorionic gonadotropin treatment in adolescents and young adults with hypogonadotropic hypogonadism promotes normal testicular growth and may promote early spermatogenesis. Fertil Steril. 2012 Oct;98(4):836-42. doi: 10.1016/j.fertnstert.2012.06.022. Epub 2012 Jul 3. Erratum in: Fertil Steril. 2013 May;99(6):1798. Dagabdhao, Preeti [corrected to Dabadghao, Preeti]. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Height | Height will be measured at every visit. | 3 months. | |
Other | Weight | Weight will be measured at every visit. | 3 months. | |
Other | Feeling of inferiority scale score | Feeling of inferiority scale scores will be obtained using feeling of inferiority scale. | 3 months. | |
Primary | Sperm 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. | 6 months. | |
Secondary | 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. | 6 months. | |
Secondary | 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. | 6 months. | |
Secondary | The time for sperm to appear during treatment | The time for the sperm firstly appeared in the semen will be recorded. | 6 months. | |
Secondary | Serum testosterone levels | The serum testosterone levels will be tested in every visit. | 3 months. | |
Secondary | Testicular volume | Testicular volume will be measured using a Prader orchidometer. | 3 months. | |
Secondary | Penis length | Penis length will be measured from the pubic symphysis to glans using a vernier caliper. | 3 months. | |
Secondary | Pubic hair | Pubic hair will be evaluated according to Tanner pubertal stages. | 3 months. | |
Secondary | Genitalia | Genitalia will be evaluated according to Tanner pubertal stages. | 3 months. |
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