The Effect of KB-120 Small Molecular Nutrient in Women With Decreased Ovarian Reserve

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of KB-120 Small Molecular Nutrient in Women With Decreased Ovarian Reserve

Conditions
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Diminished Ovarian Reserve

Intervention / Treatment
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* Dietary Supplement: KB-120 small molecular nutrient and vitamin E
* Dietary Supplement: Vitamin E


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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 | Dietary Supplement: KB-120 small molecular nutrient and vitamin E<br>* 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<br>Dietary Supplement: Vitamin E<br>* Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles<br>|
| Active Comparator: control group<br>Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles | Dietary Supplement: Vitamin E<br>* Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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） | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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） |