Clinical trial NCT05485610: Effect of NMN (Nicotinamide Mononucleotide) on Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)
Official title: Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diminished Ovarian Reserve
Premature Ovarian Insufficiency
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The comparison of the gut microbiota composition
timeFrame: before and after 2, 8, 12 weeks of intervention
measure: The alterations of gut metabolites
timeFrame: before and after 2, 8, 12 weeks of intervention
measure: Blood sugar level
timeFrame: before and after 2, 8, 12 weeks of intervention
measure: Fasting insulin
timeFrame: before and after 2, 8, 12 weeks of intervention
measure: Endocrine hormones including AMH
timeFrame: before and after 3 months of intervention
measure: Ovarian volume
timeFrame: before and after 3 months of intervention
measure: Follicle number
timeFrame: before and after 3 months of intervention
measure: Blood NAD+ level
timeFrame: before and after 2, 8, 12 weeks of intervention
measure: Changes in NAD-related metabolites in urine
timeFrame: before and after 2, 8, 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: