Long-term treatment with hCG or hCG plus hMG for men with low testosterone levels

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

This study is testing whether long-term treatment with hCG alone or with hMG can help men with low testosterone levels feel better and improve their health.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Male
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT03687606 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of long-term use of human chorionic gonadotropin (hCG) alone or in combination with human menopausal gonadotropin (hMG) in male patients diagnosed with isolated hypogonadotropic hypogonadism (IHH). Participants will be divided into three groups: one receiving hCG alone, another receiving hCG for six months followed by hMG, and the last receiving both hCG and hMG from the start. The study aims to determine the differences in efficacy and safety between these treatment regimens, addressing gaps in previous research that lacked randomized controlled trials with adequate sample sizes and follow-up durations.

Who should consider this trial

Good fit: Ideal candidates are males aged 18 to 45 with low testosterone levels and a desire for fertility.

Not a fit: Patients with primary or acquired hypogonadism or those who have previously undergone certain hormone treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve testosterone levels and fertility outcomes for men with isolated hypogonadotropic hypogonadism.

How similar studies have performed: Previous studies have shown some efficacy of hCG and hMG treatments, but this study aims to provide more definitive comparisons and insights.

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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Jihong Liu, M.D — Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
• Study coordinator: Hao Xu, M.D

Conditions Isolated Hypogonadotropic Hypogonadism; Kallmann Syndrome; Infertility; Gonadotropin treatment; human chorionic gonadotropin; human menopausal gonadotropin