跳至主要内容
临床试验/NCT06629636
NCT06629636招募中不适用

Investigate the Efficacy of Using NMN to Improve Embryo Development Capacity and IVF Success Rate in Patients Who Have Experienced IVF Failures.

Sunkaky Medical Cooperation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Embryo development rate

研究概览

简要总结

The objective of this study is to investigate the efficacy of NMN supplementation in enhancing embryo developmental capacity and improving IVF success rates in patients experiencing IVF failures.

详细描述

Reproductive aging is an irreversible process characterized by a decline in oocyte quality, posing a significant challenge to fertility and often leading to unsuccessful outcomes in assisted reproductive technologies. Repeated ART failures can result in substantial burdens for patients, both financially and emotionally. Extensive clinical and preclinical data have established a strong correlation between age-related decline in egg quality and mitochondrial deterioration, resulting in decreased energy production within oocytes. Notably, a reduction in nicotinamide adenine dinucleotide (NAD+ / NADH) concentrations, a crucial redox cofactor and enzyme-substrate essential for energy metabolism, DNA repair, and epigenetic homeostasis, has been observed in various tissues with age.

Recent studies on mice have indicated that Nicotinamide mononucleotide supplementation may mitigate the age-related decline in NAD(P)H levels, enhancing the quality of aged oocytes. This improvement is achieved by promoting both nuclear and cytoplasmic maturation, ensuring euploidy and fertilization competence, ultimately leading to an increased ovulation rate and improved fertility. Moreover, NMN has been shown to restore mitochondrial function in aged oocytes, effectively suppressing the accumulation of reactive oxygen species and DNA damage, and subsequently reducing apoptosis.

Clinical studies have further corroborated the safety and tolerability of NMN supplementation, with daily oral doses of up to 900 mg demonstrating an increase in blood NAD concentrations. Furthermore, research suggests that a daily oral dose of 900 mg maximizes clinical efficacy, as evidenced by blood NAD concentration and physical performance.

This study adopts a triple-blind, randomized, placebo-controlled, prospective pilot study design. This prospective study aims to evaluate the effects of dietary supplementation with 900mg of NMN on ART outcomes in individuals experiencing in vitro fertilization failures attributed to compromised oocyte and embryo quality.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
32 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Agree to participate in the study
  • •32-42 years old
  • •Having at least one previous embryo implantation failure
  • •History of low Embryo quality at day3 or day5 (according to Veeck's and Gardner's Criteria)
  • •No major uterine or ovarian abnormalities
  • •BMI level 18-25kg/m2

排除标准

  • •Ovarian endometriosis with Chocolate cysts (AFS type 3 and 4)
  • •Patients who have taken different supplements such as coenzyme Q10, vitamin E, carnitine,niacin, nicotinamide, or other vitamin B3-related etc. within the previous month
  • •Any medical contraindication of oocyte retrieval or subsequent procedures
  • •Couples where the husband presents with severe sperm abnormalities
  • •Couples where the husband presents <5 million/mL motile sperm
  • •Uterine structural anomalies
  • •Polycystic ovaries
  • •Premature ovarian failure
  • •Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
  • •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.
  • •Cancer patients or receiving chemo/radiotherapy treatment within the past 3 years.

研究组 & 干预措施

NMN intervention

Active Comparator

NMN capsules (total of 900mg/day) for 8 weeks

干预措施: NMN capsule (Dietary Supplement)

Placebo intervention

Placebo Comparator

NMN-free placebo capsules for 8 weeks

干预措施: Placebo (Other)

结局指标

主要结局

Embryo development rate

时间窗: Up to 8 weeks post-intervention

Analyze and compare the transferable embryo rate per zygote on day 3 in between NMN and placebo intervention groups.

Changes in metabolic status

时间窗: Up to 8 weeks post-intervention

Analyze and compare the NAD+/NADH level in serum and follicular fluid in both NMN and placebo groups

Clinical pregnancy rate

时间窗: Up to 12months post-intervention

Compare ongoing clinical pregnancy rates between NMN and placebo groups

次要结局

  • Additional in vitro fertilization - outcome indicators(Up to 8 weeks post-intervention)
  • Live Birth rates(Up to 24 months post-intervention)
  • Endocrine hormones including AMH(Up to 8 weeks post-intervention)
  • Average egg retrieval capacity per person(Up to 8 weeks post-intervention)
  • Chemical pregnancy rate(Up to 12months post-intervention)
  • Pregnancy complication(Up to 24 months post-intervention)
  • Abortion rate(Up to 24 months post-intervention)

研究者

发起方
Sunkaky Medical Cooperation
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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