Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH)

Infertility Clinical Trial

— IHH  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03687606
• Other study ID #: TJ-IRB20180906
• Status: Recruiting
• Phase: Phase 4
• Start date: October 18, 2018
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2020
• Source: Tongji Hospital
• Contact: Hao Xu, M.D
• Phone: +86-15872427301
• Email: haoxutjmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hypogonadism
• Infertility
• Isolated Hypogonadotropic Hypogonadism
• Kallmann Syndrome

Intervention

Drug:
• Human Chorionic Gonadotropin
White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.
• human menopausal gonadotropin
White freeze-dried cake or powder with specification of 75IU.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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

Outcome

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.