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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Sperm density
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18, ≤ 45 years old;
- •Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner score ﹤ 5;
- •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);
- •With or without olfactory loss/reduction;
- •Other pituitary hormone levels are normal;
- •Head MRI examination is normal;
- •Fertility is desired currently or will be desired in the future;
- •Understand and sign the informed consent form.
排除标准
- •Primary hypogonadism;
- •Acquired hypogonadotrophic hypogonadism;
- •A history of treatment with pulsed GnRH, hCG and FSH related hormones;
- •Receive testosterone replacement therapy for more than 6 months;
- •History of cryptorchidism or cryptorchidism;
- •The sperm density before treatment ≥1×10^6/ml;
- •Moderate or severe liver and kidney dysfunction (ALT>120IU/L, AST>80IU/L, CR>115μmol/L);
- •The karyotype is 45,X or 47,XXY and 48, XXXY and other abnormal karyotypes;
- •True hermaphroditism and pseudohermaphroditism;
- •Sex hormone abnormalities caused by adrenal lesions;
- •Hypogonadism secondary to other systemic diseases;
- •Abnormal secretion of hormones caused by brain lesions (such as pituitary tumors);
- •There are other hormone abnormalities in the pituitary;
- •There are contraindications for the treatment with hCG or hMG.
研究组 & 干预措施
Human Chorionic Gonadotropin alone
Human Chorionic Gonadotropin 2000U~6000U, intramuscular injection, two times per week for 3 years.
干预措施: Human Chorionic Gonadotropin (Drug)
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.
干预措施: Human Chorionic Gonadotropin (Drug)
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.
干预措施: human menopausal gonadotropin (Drug)
hCG and hMG
Human Chorionic Gonadotropin 2000U~6000U and 75~150IU human menopausal gonadotropin, intramuscular injection, two times per week for 3 years.
干预措施: Human Chorionic Gonadotropin (Drug)
hCG and hMG
Human Chorionic Gonadotropin 2000U~6000U and 75~150IU human menopausal gonadotropin, intramuscular injection, two times per week for 3 years.
干预措施: human menopausal gonadotropin (Drug)
结局指标
主要结局
Sperm density
时间窗: 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.
次要结局
- Serum testosterone levels(3 months.)
- The time for sperm to appear during treatment(6 months.)
- Pubic hair(3 months.)
- Semen volume(6 months.)
- Sperm activity(6 months.)
- Testicular volume(3 months.)
- Penis length(3 months.)
- Genitalia(3 months.)
研究者
Jihong Liu
Principal Investigator, Clinical Professor
Tongji Hospital