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【ChiCTR-IIC-16010249】高能量聚焦式超音波（HIFU)治療無排卵性不孕的卵巢多囊症婦女之劑量研究

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基本信息

登记号

ChiCTR-IIC-16010249

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2016-12-22

临床申请受理号

靶点

适应症

卵巢多囊症

试验通俗题目

高能量聚焦式超音波（HIFU)治療無排卵性不孕的卵巢多囊症婦女之劑量研究

试验专业题目

高能量聚焦式超音波（HIFU)治療無排卵性不孕的卵巢多囊症婦女之劑量研究

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

高能量聚焦式超音波（HIFU)治療無排卵性不孕的卵巢多囊症婦女之劑量

试验分类

试验类型

单臂

试验分期

治疗新技术

随机化

盲法

试验项目经费来源

试验范围

目标入组人数

实际入组人数

第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

1. Premenopausal women aged 18 to 40 years diagnosed with PCOS with anovulatory infertility; 2. Ability to give informed consent; 3. Body mass index <30 kg/m2; 4. Not on hormonal therapy (GnRH or combined oral contraceptive pills - COC) at the time of HIFU treatment; 5. No previous history of laparoscopic ovarian drilling or ovarian surgery; 6. Women with patent bilateral tubes; 7. Failure to achieve ovulation or pregnancy with incremental doses of clomiphene citrate; 8. Ability to give communicate clearly with a nurse or physician during HIFU treatment; 9. Women willing and able to comply with study requirements.；

排除标准

1. Pre-existing thyroid problem or hyperprolactinaemia which may cause anovulation; 2. Those with pre-existing compromised ovarian failure as evident by day 2 FSH >10IU/L or an AMH value of <0.75ng/ml before the treatment; 3. Pregnant or lactating; 4. Presence of active pelvic inflammatory disease, genital or extra-genital malignancy; 5. Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU; 6. Unable to give consent or those who are unable for regular follow- ups after the study; 7. Those with an intrauterine device in situ; 8. Those with tattoos or metalic implants over their abdomen; 9. Male partner with moderate to severe male factor.；

研究者信息

研究负责人姓名

试验机构

香港中文大學威爾斯親王醫院婦產科學系

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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