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

Diminished Ovarian Reserve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06081257
• Other study ID #: IRB-20230158-R
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: July 5, 2024

Study information

• Verified date: June 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diminished Ovarian Reserve

Intervention

Dietary Supplement:
• "KB-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
• Vitamin E
Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)