Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ovarian volume
研究概览
简要总结
The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve (including premature ovarian insufficiency).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Ovarian volume
时间窗: before 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 composition
时间窗: before 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 insulin
时间窗: before and after 2, 8, 12 weeks of intervention
Changes in plasma insulin concentration after the intervention.
Follicle number
时间窗: before 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+ level
时间窗: before and after 2, 8, 12 weeks of intervention
Changes in whole blood NAD+ level after the intervention.
Endocrine hormones including AMH
时间窗: before and after 3 months of intervention
Changes in endocrine hormones including AMH levels in serum after the intervention.
The alterations of gut metabolites
时间窗: before and after 2, 8, 12 weeks of intervention
Determination the alterations of gut metabolites before and after NMN intervention by metabolomics.
Blood sugar level
时间窗: before and after 2, 8, 12 weeks of intervention
Changes in plasma glucose concentration after the intervention.
Changes in NAD-related metabolites in urine
时间窗: before and after 2, 8, 12 weeks of intervention
Determination the changes of NAD-related metabolites in urine before and after NMN intervention by metabolomics.
次要结局
未报告次要终点