Clinical trial NCT06081257: The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve
Official title: The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diminished Ovarian Reserve
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentration of serum FSH 1
timeFrame: on the 3rd day of the 2nd menstruation（each cycle is 23-30 days）
measure: Concentration of serum FSH 2
timeFrame: on the 3rd day of the 4th menstruation（each cycle is 23-30 days）
measure: Concentration of serum AMH 1
timeFrame: on the 3rd day of the 2nd menstruation（each cycle is 23-30 days）
measure: Concentration of serum AMH 2
timeFrame: on the 3rd day of the 4th menstruation（each cycle is 23-30 days）
Secondary outcomes:
measure: The number of days of the menstrual cycle 1
timeFrame: At the end of Cycle 1 （each cycle is 23-30 days）
measure: The number of days of the menstrual cycle 3
timeFrame: At the end of Cycle 3（each cycle is 23-30 days）
measure: The diameter of dominant follicle and the number of days required for ovulation 1
timeFrame: At the end of Cycle 1 （each cycle is 23-30 days）
measure: The diameter of dominant follicle and the number of days required for ovulation 2
timeFrame: At the end of Cycle 3 （each cycle is 23-30 days）
measure: pregnancy rate for women trying to get pregnant 1
timeFrame: At the end of Cycle 1 （each cycle is 23-30 days）
measure: pregnancy rate for women trying to get pregnant 2
timeFrame: At the end of Cycle 3 （each cycle is 23-30 days）
Other outcomes:
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