Diminished Ovarian ReserveNCT06081257
The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve
A study testing "KB-120" small molecular nutrient and vitamin E and Vitamin E in people with Diminished Ovarian Reserve, run by Women's Hospital School Of Medicine Zhejiang University.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- "KB-120" small molecular nutrient and vitamin E and Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2023to 5 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
"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
- Being tested
- "KB-120" small molecular nutrient and vitamin E, Vitamin E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"KB-120" small molecular nutrient and vitamin EDietary 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
Vitamin EDietary supplement
Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum FSH 1
Blood samples were collected on the 3rd day of the 2nd menstruation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The number of days of the menstrual cycle 1
Measured: At the end of Cycle 1 （each cycle is 23-30 days）
The number of days of the menstrual cycle 3
The number of days of the menstrual cycle 3
Measured: 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
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
Measured: 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
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
Measured: At the end of Cycle 3 （each cycle is 23-30 days）
pregnancy rate for women trying to get pregnant 1
pregnancy rate for women trying to get pregnant
Measured: At the end of Cycle 1 （each cycle is 23-30 days）
pregnancy rate for women trying to get pregnant 2
pregnancy rate for women trying to get pregnant
Measured: At the end of Cycle 3 （each cycle is 23-30 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completion5 Feb 2024 (estimated)
- Study completion5 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081257
- Sponsor's protocol ID
- IRB-20230158-R
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve
- ClinicalTrials.gov ID
- NCT06081257
- Acronym / sponsor ID
- IRB-20230158-R
- Conditions
- Diminished Ovarian Reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 5 Feb 2024 (estimated)
- Study completion
- 5 Jul 2024 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: "KB-120" small molecular nutrient and vitamin E, Dietary Supplement: Vitamin E"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 |
| control group | Active comparator | Dietary Supplement: Vitamin EVitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "KB-120" small molecular nutrient and vitamin EThe 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 | experimental group |
| Vitamin EVitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles | Dietary supplement | control group, experimental group |
Primary outcome
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
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
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
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
6 secondary outcomes
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 3
Time frame: 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 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）
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 2
Time frame: At the end of Cycle 3 （each cycle is 23-30 days）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing "KB-120" small molecular nutrient and vitamin E and Vitamin E in people with Diminished Ovarian Reserve, run by Women's Hospital School Of Medicine Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of serum FSH 1 (time frame: on the 3rd day of the 2nd menstruation（each cycle is 23-30 days）). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.