GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia: A Single-center Prospective Study in China
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sperm retrieval rate (SRR)
研究概览
简要总结
Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA. It was generally believed that gonadotrophin treatment would be ineffective in the presence of high plasma levels of endogenous gonadotrophin.The purpose of this study is to determine whether GnRHa(gonadotropin-releasing hormone agonist) combined with hCG(human chorionic gonadotropin) and hMG(human menopausal gonadotropin) are effective in the treatment of non-obstructive azoospermia.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged 18-45 with clinical diagnosis of non-obstructive azoospermia.
- •At least testicular volume more than 8.0ml on one side .
- •FSH more than 5.5 IU/L.
排除标准
- •Subjects with anatomical abnormalities of the genital tract.
- •allergy to the drugs used for treatment.
- •Y chromosome deletions or abnormal karyotypes.
- •Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease
研究组 & 干预措施
GnRHa/ hCG/ hMG
3.6mg GnRHa (Goserelin, AstraZeneca UK Limited) every 28days for 5 months. After 2 months from the first Goserelin injection, all subjects were treated with hCG (Pregnyl, N.V. Organon Oss,Holland ) at a dose of 2000 IU once a week for 3 months. After 3 months from the first Goserelin injection, all subjects were treated with hMG (Urofollitropin for Injection, Livzon Pharm Group Inc., China) at a dose of 150 IU every 3 days for 2 months.
干预措施: GnRHa/ hCG/ hMG (Drug)
结局指标
主要结局
Sperm retrieval rate (SRR)
时间窗: 4 months
Semen analysis was performed every month from the end of the 6th month (two months after the last injection of hMG) to the end of 9th month until any sperm was found in the semen. If not sperm was found at the end of the 9th month, testicular sperm aspiration(TESA) was performed and the tissue was used for histological assessment. If any sperm was found in the semen analysis or TESA, the treatment was effective. The sperm retrieval rate was calculated.
次要结局
- Hormonal profile(9 months)
研究者
Bing Yao
Director of Center for Reproductive Medicine
Jinling Hospital, China