The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Concentration of serum FSH 1
研究概览
简要总结
"KB-120" small molecular nutrient is a structural multi-molecular natural nutrient with different components. It is produced from strains and natural plant culture-medium that can be used in food and is designed according to different efficacy of different products by multi-stage solid-liquid complex fermentation technology. The functional directions of the product series involved are: immune function damage repair, intestinal villi damage repair, sperm development machinery damage repair, ovarian function damage repair, liver function damage repair, sleep disorder function damage repair, etc.Previous studies have shown that "KB-120" has good clinical effects on improving the number and function of male germ cells.Luanbao "KB-120" is a compound plant health drink specially for women. This study intends to give "KB-120" small molecule nutrients as nutritional supplement intervention in female patients with ovarian dysfunction, and observe its influence on endocrine function, ovarian reserve function and fertility in patients with ovarian dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with low ovarian function: FSH ≥10IU/L or AMH ≤1.1ng/ml.
- •The age at the time of signing the informed consent is 20-40 years old (including 20 and 40 years old) and has not been menopausal;
- •Be willing to sign written informed consent and comply with the study protocol
排除标准
- •Patients with severe anemia or malignant tumor; Lactation or pregnancy;
- •Eating disorders or anorexia;
- •Taking hormone drugs or participating in any other study.
- •There are factors that researchers believe cannot be included in the study
结局指标
主要结局
Concentration of serum FSH 1
时间窗: on the 3rd day of the 2nd menstruation（each cycle is 23-30 days）
Blood samples were collected on the 3rd day of the 2nd menstruation
Concentration of serum FSH 2
时间窗: on the 3rd day of the 4th menstruation（each cycle is 23-30 days）
Blood samples were collected on the 3rd day of the 4th menstruation
Concentration of serum AMH 1
时间窗: on the 3rd day of the 2nd menstruation（each cycle is 23-30 days）
Blood samples were collected on the 3rd day of the 2nd menstruation
Concentration of serum AMH 2
时间窗: on the 3rd day of the 4th menstruation（each cycle is 23-30 days）
Blood samples were collected on the 3rd day of the 4th menstruation
次要结局
- The number of days of the menstrual cycle 3(At the end of Cycle 3（each cycle is 23-30 days）)
- The number of days of the menstrual cycle 1(At the end of Cycle 1 （each cycle is 23-30 days）)
- The diameter of dominant follicle and the number of days required for ovulation 1(At the end of Cycle 1 （each cycle is 23-30 days）)
- pregnancy rate for women trying to get pregnant 1(At the end of Cycle 1 （each cycle is 23-30 days）)
- pregnancy rate for women trying to get pregnant 2(At the end of Cycle 3 （each cycle is 23-30 days）)
- The diameter of dominant follicle and the number of days required for ovulation 2(At the end of Cycle 3 （each cycle is 23-30 days）)