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

October 19, 2023 updated by: Women's Hospital School Of Medicine Zhejiang University
"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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
"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
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 supplement: Vitamin E
Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles
Active Comparator: control group
Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles
Dietary supplement: Vitamin E
Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of serum FSH 1
Time Frame: 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
on the 3rd day of the 2nd menstruation（each cycle is 23-30 days）
Concentration of serum FSH 2
Time Frame: 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
on the 3rd day of the 4th menstruation（each cycle is 23-30 days）
Concentration of serum AMH 1
Time Frame: 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
on the 3rd day of the 2nd menstruation（each cycle is 23-30 days）
Concentration of serum AMH 2
Time Frame: 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
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
Time Frame: At the end of Cycle 1 （each cycle is 23-30 days）
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
Time Frame: At the end of Cycle 3（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）
pregnancy rate for women trying to get pregnant 1
Time Frame: At the end of Cycle 1 （each cycle is 23-30 days）
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
Time Frame: At the end of Cycle 3 （each cycle is 23-30 days）
pregnancy rate for women trying to get pregnant
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
Time Frame: 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
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
Time Frame: 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
At the end of Cycle 3 （each cycle is 23-30 days）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2023

Primary Completion (Estimated)

February 5, 2024

Study Completion (Estimated)

July 5, 2024

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20230158-R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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