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

NCT ID: NCT05485610

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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).

Conditions

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Diminished Ovarian Reserve Premature Ovarian Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NMN intervention

3 months of NMN

Group Type EXPERIMENTAL

NMN intervention

Intervention Type DIETARY_SUPPLEMENT

NMN capsules (total of 600mg/day) for 3 months

Placebo

3 months of NMN-free placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

NMN-free placebo capsules for 3 months

Interventions

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NMN intervention

NMN capsules (total of 600mg/day) for 3 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

NMN-free placebo capsules for 3 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Individuals who are 20 to 40 years old.
2. 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.
3. Individuals who can insist on continuous monitoring in the outpatient clinic.
4. Individuals who are not participating in other research projects currently or 3 months before the intervention.

Exclusion Criteria

1. Individuals who are during pregnant, lactation or menopause.
2. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology.
3. Individuals who had pelvic surgery.
4. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years.
5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
6. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
7. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months.
8. 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.
9. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months.
10. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
11. A medical history of severe cardiovascular and cerebrovascular diseases.
12. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
13. Individuals who drink more than 15g of alcohol per day or have a smoking habit.
14. Individuals who need drug treatment for any mental illness such as epilepsy and depression.
15. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
16. Unable or unwilling to follow the study protocol.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Jie Qiao, Ph.D.

Role: primary

+86 010-82265080

Other Identifiers

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M2022262

Identifier Type: -

Identifier Source: org_study_id

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