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

Last updated: October 9, 2022
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Perimenopause

Treatment

N/A

Clinical Study ID

NCT05485610
M2022262
  • Ages 20-40
  • Female

Study 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).

Eligibility Criteria

Inclusion

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 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.
  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 monthsbefore the intervention.

Exclusion

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 2months.
  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-relatedsupplementation, or other supplementation such as coenzyme Q10, vitamin E currently orwithin the past 3 months.
  9. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3months.
  10. Individuals with severe liver diseases or kidney disease that are ineligible toparticipate in the study.
  11. A medical history of severe cardiovascular and cerebrovascular diseases.
  12. Individuals who currently suffer from severe gastrointestinal diseases or undergogastrointestinal 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 anddepression.
  15. Individuals who suffer from infectious diseases such as hepatitis B, activetuberculosis, AIDS, etc.
  16. 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

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).

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

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