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

Not Applicable
Recruiting
Conditions
Premature Ovarian Insufficiency
Diminished Ovarian Reserve
Interventions
Other: Placebo
Dietary Supplement: NMN intervention
Registration Number
NCT05485610
Lead Sponsor
Peking University Third Hospital
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).

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
200
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo3 months of NMN-free placebo
NMN interventionNMN intervention3 months of NMN
Primary Outcome Measures
NameTimeMethod
Ovarian volumebefore and after 3 months of intervention

The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.

The comparison of the gut microbiota compositionbefore and after 2, 8, 12 weeks of intervention

Determination the gut microbiota composition change of stool samples between placebo group and intervention group by 16S metagenomic.

Fasting insulinbefore and after 2, 8, 12 weeks of intervention

Changes in plasma insulin concentration after the intervention.

Follicle numberbefore and after 3 months of intervention

The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.

Blood NAD+ levelbefore and after 2, 8, 12 weeks of intervention

Changes in whole blood NAD+ level after the intervention.

Endocrine hormones including AMHbefore and after 3 months of intervention

Changes in endocrine hormones including AMH levels in serum after the intervention.

The alterations of gut metabolitesbefore and after 2, 8, 12 weeks of intervention

Determination the alterations of gut metabolites before and after NMN intervention by metabolomics.

Blood sugar levelbefore and after 2, 8, 12 weeks of intervention

Changes in plasma glucose concentration after the intervention.

Changes in NAD-related metabolites in urinebefore and after 2, 8, 12 weeks of intervention

Determination the changes of NAD-related metabolites in urine before and after NMN intervention by metabolomics.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Peking University Third Hospital

🇨🇳

Beijing, Beijing, China

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