Diminished Ovarian Reserve
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKB-120 small molecular nutrient and vitamin E
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
DIETARY_SUPPLEMENTVitamin E
Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with low ovarian function: FSH ≥10IU/L or AMH ≤1.1ng/ml. 2. 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; 3. Be willing to sign written informed consent and comply with the study protocol
Exclusion criteria
1. Patients with severe anemia or malignant tumor; Lactation or pregnancy; 2. Eating disorders or anorexia; 3. Taking hormone drugs or participating in any other study. 4. There are factors that researchers believe cannot be included in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of serum FSH 1 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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） | 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 |
| pregnancy rate for women trying to get pregnant 2 | At the end of Cycle 3 （each cycle is 23-30 days） | pregnancy rate for women trying to get pregnant |
| 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 |
| 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 1 |
| 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 3 |
| 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） | 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 |
Outcome results
None listed