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

NCT ID: NCT03687606

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2025-10-01

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.

Conditions

Isolated Hypogonadotropic Hypogonadism; Kallmann Syndrome; Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human Chorionic Gonadotropin alone

Human Chorionic Gonadotropin 2000U\~6000U, intramuscular injection, two times per week for 3 years.

Group Type: ACTIVE_COMPARATOR

Human Chorionic Gonadotropin

Intervention Type: DRUG

White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.

hCG alone for 6 months then hMG added

Human Chorionic Gonadotropin 2000U\~6000U, intramuscular injection, two times per week for six months, then 75\~150IU human menopausal gonadotropin, intramuscular injection, two times per week, was added and last for the next 30 months.

Group Type: EXPERIMENTAL

Human Chorionic Gonadotropin

Intervention Type: DRUG

White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.

human menopausal gonadotropin

Intervention Type: DRUG

White freeze-dried cake or powder with specification of 75IU.

hCG and hMG

Human Chorionic Gonadotropin 2000U\~6000U and 75\~150IU human menopausal gonadotropin, intramuscular injection, two times per week for 3 years.

Group Type: EXPERIMENTAL

Human Chorionic Gonadotropin

Intervention Type: DRUG

White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.

human menopausal gonadotropin

Intervention Type: DRUG

White freeze-dried cake or powder with specification of 75IU.

Interventions

Human Chorionic Gonadotropin

White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.

Intervention Type: DRUG

human menopausal gonadotropin

White freeze-dried cake or powder with specification of 75IU.

Intervention Type: DRUG

Other Intervention Names

hCG; hMG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jihong Liu

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jihong Liu, M.D

Role: PRINCIPAL_INVESTIGATOR

Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Xu, M.D

Role: CONTACT

haoxutjmu@163.com

+86-15872427301

Yinwei Chen, M.D

Role: CONTACT

913904361@qq.com

+86-15527953877

Facility Contacts

Hao Xu, M.D

Role: primary

+86-15872427301

References

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.

Reference Type: BACKGROUND

PMID: 22763096 (View on PubMed)

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):979-990. doi: 10.1016/j.fertnstert.2008.07.1742. Epub 2008 Oct 18.

Reference Type: BACKGROUND

PMID: 18930190 (View on PubMed)

Other Identifiers

TJ-IRB20180906

Identifier Type: -

Identifier Source: org_study_id