Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 76
- 主要终点
- pregnancy in the female partner
研究概览
简要总结
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
详细描述
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
The primary endpoint was the achievement of pregnancy in female partner. Secondary endpoints were time to actual attainment of various sperm thresholds: sperm concentration>0*10^6/ml , >1.0 *10^6/ml and >15 *10^6/ml, respectively.
The clinical and laboratory characteristics including testicular and prostatic volume, Tanner stage for pubic hair and genital, serum hormone levels [especially serum testosterone,luteinizing hormone (LH) , and Follicle-Stimulating Hormone (FSH) levels], sperm concentration per ejaculate, and adverse events at baseline and at the end of treatment were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age greater than 16 yr
- •Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism
- •Hypogonadal serum testosterone levels (<166ng/dl) in the presence of low or normal gonadotropins
- •Normal levels of other anterior pituitary hormones
- •Normal MRI scans of the hypothalamo-pituitary region
- •Had discontinued any prior treatment (testosterone or gonadotropin therapy) for at least three months before enrollment
排除标准
- •With any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study
- •Congenital hypopituitarism
- •Any medical or surgical conditions possibly affecting the experiment result
- •Any clinically significant allergic diseases or allergic to the study drugs
- •Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
研究组 & 干预措施
Pulsatile Gonadotropin Releasing Hormone
Pulsatile Gonadotropin Releasing Hormone: subjects in the GnRH group initiated a regimen of pulsatile GnRH administered subcutaneously via a portable infusion pump for 18 months.
干预措施: Pulsatile Gonadotropin Releasing Hormone (Drug)
combination gonadotropin therapy
combined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months
干预措施: Human chorionic gonadotropin (Drug)
combination gonadotropin therapy
combined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months
干预措施: Urinary Follicle-Stimulating Hormone (Drug)
结局指标
主要结局
pregnancy in the female partner
时间窗: 18 months
次要结局
- first appearance of sperm (month after treatment)(18 months)
- first time with sperm density>1*10^6/ml（month after treatment）(18 months)
- first time with sperm density>15*10^6/ml（month after treatment）(18 months)
研究者
Guang Ning
the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital
Shanghai Jiao Tong University School of Medicine