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【ChiCTR-INC-16009306】褪黑素联合DHEA治疗卵巢储备功能下降的临床试验

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基本信息

登记号

ChiCTR-INC-16009306

试验状态

正在进行

药物名称

美乐托宁

药物类型

化药

规范名称

美乐托宁

首次公示信息日的期

2016-10-03

临床申请受理号

靶点

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适应症

卵巢储备功能下降

试验通俗题目

褪黑素联合DHEA治疗卵巢储备功能下降的临床试验

试验专业题目

褪黑素联合DHEA治疗卵巢储备功能下降的临床试验

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

410008

联系人通讯地址

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临床试验信息

试验目的

The aim of the study is whether oral melatonin plus DHEA administration can improve the outcome of IVF in Diminished Ovarian Reserve (DOR) patients as follows: To determine embryological outcome; To determine biochemical outcome (to find out optimum hormono-microfollicular enviroment for high quality oocyte through comparing Melatonin, Estrogen, Progestrogen and LH in follicular fluidin leading follicles of different group patients including PCOS, Normal Ovarian Reserve, DOR patients with or without Melatonin plus DHEA treated).

试验分类

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试验类型

横断面

试验分期

治疗新技术

随机化

Randomization will be computerized.

盲法

试验项目经费来源

中南大学湘雅医院生殖医学中心

试验范围

目标入组人数

实际入组人数

第一例入组时间

2016-09-25

试验终止时间

2017-02-27

是否属于一致性

入选标准

For DOR patient: The criteria for DOR included AMH, FSH and Estradiol (E2) levels as well as antral follicle counts (AFC) or retrieved oocyte number. The patients were considered to have DOR if they have had serum AMH levels ≤ 1 ng/ml or an AFC≤5 on Day 3 of a spontaneous cycle or retrieved oocyte number ≤3. For NOR patient (Normal Ovarian Reserve): The criteria for Normal Ovarian Reserve (NOR) patients included AMH>3 ng/ml, FSH≤10 IU/ml, an AFC≥8 and or retrieved oocyte number ≥6. For PCOS patient: The criteria for PCOS patients included AMH>10 ng/ml, FSH/LH ratio >2, AFC for each ovaries ≥ 12(Total ≥ 25) and or retrieved oocyte number ≥ 15 or clinical and/or biochemical signs of hyperandrogenism.；

排除标准

The patients with known conditions affecting ovarian reserve, including ovarian surgery, polycystic ovarian syndrome, endometriosis, post chemo and radiation therapy recovery or BMI ≥ 25 will be excluded.；

研究者信息

研究负责人姓名

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试验机构

中南大学湘雅医院生殖医学中心

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

410008

联系人通讯地址