NCT06426355招募中不适用
The Effeciency of Nicotinamide Mononucleotide (NMN) in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With Decreased Ovarian Reserve（DOR): a Randomized Double-blind Placebo Control Clinical Trail
适应症
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
- The clinical pregnancy rate
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 and the outcomes of IVF/ICSI-ET.
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.
- •At least two of the following three conditions should be met:
- •The concentrations of anti-Mullerian hormone < 1.1 ng/ml,
- •the values of antral follicle count was less than 7
- •serum concentrations of day-3 follicle-stimulating hormone (FSH)： 10 IU/L ≤ FSH<20 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.
- •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
The clinical pregnancy rate
时间窗: through study completion, an average of 2 year
The pregnancy rate of IVF/ICSI-ET
次要结局
- In vitro fertilization - outcome indicators of embryo culture(Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo)
- live birth rate(after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo)
- abortion rate(after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo)
- Endocrine hormones including AMH(Within three months after the end of treatment with NMN or placebo)
- Follicle number(Within three months after the end of treatment with NMN or placebo)
- the condition of newborn births(after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo)
- Biochemical pregnancy rate(after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo)
- pregnancy complications(after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo)
- Metabolism-related index(Within three months after the end of treatment with NMN or placebo)
研究者
研究点 (1)
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