Last updated: October 9, 2022
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Perimenopause
Treatment
N/AClinical Study ID
NCT05485610
M2022262
Ages 20-40 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Individuals who are 20 to 40 years old.
- The concentrations of anti-Mullerian hormone < 1.1 ng/ml, the values of antralfollicle count range from less than 5 to less than 7 and two recordings of serumconcentrations of day-3 follicle-stimulating hormone (FSH) ≥10 IU/L.
- Individuals who can insist on continuous monitoring in the outpatient clinic.
- Individuals who are not participating in other research projects currently or 3 monthsbefore the intervention.
Exclusion
Exclusion Criteria:
- Individuals who are during pregnant, lactation or menopause.
- Individuals who had non-46-XX karyotype, or attributed to known genetic etiology.
- Individuals who had pelvic surgery.
- Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years.
- Individuals who need regular medication to treat chronic diseases such as diabetes,hypertension, gout, hyperuricemia, etc.
- Individuals who currently receiving weight-loss drugs or surgery or within the past 2months.
- Use of medications or traditional Chinese medicine that affect hormone levels,appetite, carbohydrate absorption, and metabolism within the past 3 months.
- Individuals who take niacin, nicotinamide, or other vitamin B3-relatedsupplementation, or other supplementation such as coenzyme Q10, vitamin E currently orwithin the past 3 months.
- Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3months.
- Individuals with severe liver diseases or kidney disease that are ineligible toparticipate in the study.
- A medical history of severe cardiovascular and cerebrovascular diseases.
- Individuals who currently suffer from severe gastrointestinal diseases or undergogastrointestinal resection that may affect nutrient absorption.
- Individuals who drink more than 15g of alcohol per day or have a smoking habit.
- Individuals who need drug treatment for any mental illness such as epilepsy anddepression.
- Individuals who suffer from infectious diseases such as hepatitis B, activetuberculosis, AIDS, etc.
- Unable or unwilling to follow the study protocol.
Study Design
Total Participants: 200
Study Start date:
July 01, 2022
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Peking University Third Hospital
Beijing, Beijing 100191
ChinaActive - Recruiting
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