The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 80
- Primary Endpoint
- Concentration of serum AMH 2
Study Overview
Brief Summary
"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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
experimental group
"KB-120" small molecule nutrients, taken orally once a day in one bag (30ml), and vitamin E100mg taken orally 2 times a day for a total of 3 menstrual cycles
Intervention: "KB-120" small molecular nutrient and vitamin E (Dietary Supplement)
control group
Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles
Intervention: Vitamin E (Dietary Supplement)
experimental group
"KB-120" small molecule nutrients, taken orally once a day in one bag (30ml), and vitamin E100mg taken orally 2 times a day for a total of 3 menstrual cycles
Intervention: Vitamin E (Dietary Supplement)
Outcomes
Primary Outcomes
Concentration of serum AMH 2
Time Frame: 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 FSH 1
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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）)
- The number of days of the menstrual cycle 3(At the end of Cycle 3（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）)