IVF Namba Clinic, Sankaky Medical Corporation
Osaka, 5500015, Japan
Location status: Recruiting
NCT Number: NCT06629636
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.
Interested in participating?
Request Info32 year–42 year
Female
Interventional
Not applicable
Osaka, 5500015, Japan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total of 900mg/day for 8 weeks
NMN-free placebo capsules for 8 weeks
Time frame: 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.
Time frame: Up to 8 weeks post-intervention
Analyze and compare the NAD+/NADH level in serum and follicular fluid in both NMN and placebo groups
Time frame: Up to 12months post-intervention
Compare ongoing clinical pregnancy rates between NMN and placebo groups
Time frame: Up to 8 weeks post-intervention
Analyze and compare the quality of embryos on day 3, 5 or 6 between two groups
Time frame: Up to 8 weeks post-intervention
Analyze and compare the rate of blastocyst development on day 5 and 6 in between two groups
Time frame: Up to 24 months post-intervention
Compare live Birth rate following the intervention in both groups
Time frame: Up to 8 weeks post-intervention
Changes in endocrine hormones including AMH levels in serum after the interventions.
Time frame: Up to 8 weeks post-intervention
Compare the number of antral follicles in each ovary will be determined using transvaginal ultrasonography in both groups.
Time frame: Up to 8 weeks post-intervention
Number of average recruited MII oocytes in both groups
Time frame: Up to 12months post-intervention
Compare the chemical pregnancy rates between the two groups.
Time frame: Up to 24 months post-intervention
Rate of pregnancy complication in both groups
Time frame: Up to 24 months post-intervention
Compare the abortion rates in both groups
Time frame: Up to 8 weeks post-intervention
Compare the rate of fertilization in between two groups
Time frame: Up to 8 weeks post-intervention
Rate of abnormal fertilization in both groups
Time frame: Up to 8 weeks post-intervention
The rate of non-transferable embryos in both groups
Contact information is provided by the study sponsor or research team.
Masaya Y., Masaya Yamanaka, BSc
CONTACT
Udayanga KGS., Udayanga Gamage, BVSc, PhD
CONTACT
Sunkaky Medical Cooperation
Industry
Investigate the Efficacy of Using NMN to Improve Embryo Development Capacity and IVF Success Rate in Patients Who Have Experienced IVF Failures.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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