NCT05485610RecruitingNot Applicable

Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)

Peking University Third Hospital1 site in 1 country200 target enrollmentStarted: July 1, 2022Last updated: October 12, 2022

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: Peking University Third Hospital
Enrollment: 200
Locations: 1
Primary Endpoint: Fasting insulin

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve (including premature ovarian insufficiency).

Detailed Description

This study aims to evaluate the effects of NMN on reproductive endocrine, immune homeostasis, and reproductive outcomes in women with DOR (including POI), and to explore its underlying mechanisms to provide the intervention strategies for DOR (including POI).

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Basic Science
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 20 Years to 40 Years (Adult)
Sex: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

•Individuals who are 20 to 40 years old.
•The concentrations of anti-Mullerian hormone < 1.1 ng/ml, the values of antral follicle count range from less than 5 to less than 7 and two recordings of serum concentrations 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 months before the intervention.

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 2 months.
•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-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months.
•Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months.
•Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
•A medical history of severe cardiovascular and cerebrovascular diseases.
•Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal 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 and depression.
•Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
•Unable or unwilling to follow the study protocol.

Arms & Interventions

Placebo

Placebo Comparator

3 months of NMN-free placebo

Intervention: Placebo (Other)

NMN intervention

Experimental

3 months of NMN

Intervention: NMN intervention (Dietary Supplement)