Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06081257
Other study ID # IRB-20230158-R
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT04972877 - Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve N/A
Recruiting NCT04447872 - The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol N/A
Recruiting NCT05277948 - Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR) N/A
Recruiting NCT04711772 - Whole-genome Sequencing Study in Patients With Diminished Ovarian Reserve
Recruiting NCT03670407 - Follicular Activation by Fragmentation of Ovarian Tissue N/A
Recruiting NCT06072794 - A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI) Phase 1
Recruiting NCT06096766 - the Correlation Between Ovarian Function and Serum Biomarkers
Not yet recruiting NCT02099916 - Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF Phase 2/Phase 3
Recruiting NCT06426355 - The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR N/A
Recruiting NCT04275700 - Study of PRP in Women With Evidence of Diminished Ovarian Reserve N/A
Recruiting NCT06223178 - Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve N/A
Not yet recruiting NCT05577455 - Efficacy of Traditional Chinese Medicine on Ameliorating IVF-ET Outcomes of Diminished Ovarian Reserve Patients Phase 3
Not yet recruiting NCT05459493 - A Clinical Study of Chinese Herbal Compound TJAOA101 in Therapy of Diminished Ovarian Reserve Early Phase 1
Recruiting NCT05665010 - Precise Stratification of Genetic Risk of Ovarian Function Impairment
Not yet recruiting NCT05385848 - Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study N/A
Terminated NCT01614067 - Delayed Start to Ovarian Stimulation Phase 4
Recruiting NCT06395623 - Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics
Recruiting NCT05847283 - DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT N/A
Recruiting NCT05485610 - Effect of NMN (Nicotinamide Mononucleotide) on Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency) N/A
Completed NCT04237909 - Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency N/A