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"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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | "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 |
|
| control group | Active Comparator | Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "KB-120" small molecular nutrient and vitamin E | Dietary Supplement | The experimental group was given oral "KB-120" small molecular nutrients, once a day, once a bag (30ml), and vitamin E100mg orally twice a day for a total of 3 menstrual cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of serum FSH 1 | Blood samples were collected on the 3rd day of the 2nd menstruation | on the 3rd day of the 2nd menstruation（each cycle is 23-30 days） |
| Concentration of serum FSH 2 | Blood samples were collected on the 3rd day of the 4th menstruation | on the 3rd day of the 4th menstruation（each cycle is 23-30 days） |
| Concentration of serum AMH 1 | Blood samples were collected on the 3rd day of the 2nd menstruation | on the 3rd day of the 2nd menstruation（each cycle is 23-30 days） |
| Concentration of serum AMH 2 | Blood samples were collected on the 3rd day of the 4th menstruation | on the 3rd day of the 4th menstruation（each cycle is 23-30 days） |
| Measure | Description | Time Frame |
|---|---|---|
| The number of days of the menstrual cycle 1 | The number of days of the menstrual cycle 1 | At the end of Cycle 1 （each cycle is 23-30 days） |
| The number of days of the menstrual cycle 3 | The number of days of the menstrual cycle 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Vitamin E | Dietary Supplement | Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles |
|
| 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 1 | The follicle development of patients was monitored by ultrasound during the 1st menstrual cycle, and the monitoring interval was determined according to the clinical experience of clinicians and the development of patients' follicles | 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 2 | The follicle development of patients was monitored by ultrasound during the 3rd menstrual cycle, and the monitoring interval was determined according to the clinical experience of clinicians and the development of patients' follicles | At the end of Cycle 3 （each cycle is 23-30 days） |
| pregnancy rate for women trying to get pregnant 1 | pregnancy rate for women trying to get pregnant | At the end of Cycle 1 （each cycle is 23-30 days） |
| pregnancy rate for women trying to get pregnant 2 | pregnancy rate for women trying to get pregnant | At the end of Cycle 3 （each cycle is 23-30 days） |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |