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

NCT06081257 | Unknown

• 1 other identifier: IRB-20230158-R
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diminished Ovarian Reserve

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

  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

  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

  At the end of Cycle 3 （each cycle is 23-30 days）

• pregnancy rate for women trying to get pregnant 1

  At the end of Cycle 1 （each cycle is 23-30 days）

Study Arms (2)

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

Dietary Supplement: "KB-120" small molecular nutrient and vitamin E; Dietary Supplement: Vitamin E

control group

ACTIVE COMPARATOR

Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles

Dietary Supplement: Vitamin E

Interventions

"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

experimental group

Vitamin E DIETARY_SUPPLEMENT

Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles

control group; experimental group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

MeSH Terms

Interventions

Vitamin E

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: October 13, 2023
• Study Start: October 15, 2023
• Primary Completion: February 5, 2024
• Study Completion: July 5, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-06