Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of serum Luteinizing Hormone(LH) value
研究概览
简要总结
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.
详细描述
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy. The hormonal response of the hypothalamic-pituitary-gonad axis was assessed after pulsatile GnRH replacement by measurement of serum T, LH and FSH. A standard seminal fluid analysis was performed in men who could produce an ejaculate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years or over male patients;
- •Absent or incomplete puberty development;
- •Serum testosterone values below 3.47 nmol/L by low or normal serum LH and FSH concentrations.
- •at least two or more pituitary hormone deficiencies
- •Brain MRI showed absent and thin pituitary stalk, or pituitary hypoplasia and/or ectopic posterior pituitary.
排除标准
- •cryptorchidism history
- •other causes of hypopituitarism or severe systemic disease
研究组 & 干预措施
treatment group
patients were administered with pulsatile gonadotropin-releasing hormone (GnRH )therapy for 12 months at an interval of 90 minutes.The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L.
干预措施: Gonadotropin-releasing Hormone (Drug)
结局指标
主要结局
Change of serum Luteinizing Hormone(LH) value
时间窗: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Luteinizing hormone (LH) is measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.24-8.62 IU/L. Initial efficacy is evaluated based on the values of serum LH and serum total testosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
Change of serum Follicle-Stimulating Hormone (FSH) value
时间窗: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Follicle-stimulating hormone (FSH) are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.27-19.26 IU/L.
Change of serum total testosterone value
时间窗: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Total testosterone levels are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 175-781 ng/dL.Initial efficacy is evaluated based on the values of serum LH and serum totaltestosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
次要结局
- Change of testicular volume(Baseline and at 1m,3m, 6m, 9m and 12m post treatment)
- Change of sperm counts by routine semen analysis(Baseline and at 3m, 6m, 9m and 12m post treatment)
- the rate of impregnating subject's wife(at 3m, 6m, 9m and 12m post treatment)
研究者
wuxueyan
professor,MD
Peking Union Medical College Hospital