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NCT Number: NCT06629636

Investigate the Efficacy of Using NMN to Improve Embryo Development Capacity.

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.

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Key information

Age range

32 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVF Namba Clinic, Sankaky Medical Corporation

Osaka, 5500015, Japan

Location status: Recruiting

Location contact

Naoharu M., Naoharu Morimoto, MD

CONTACT

[email protected]

+81 6 6534 8824

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

NMN capsule

Dietary Supplement

Total of 900mg/day for 8 weeks

Placebo

Other

NMN-free placebo capsules for 8 weeks

Primary outcomes

  1. Embryo development rate

    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.

  2. Changes in metabolic status

    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

  3. Clinical pregnancy rate

    Time frame: Up to 12months post-intervention

    Compare ongoing clinical pregnancy rates between NMN and placebo groups

  4. Embryo development rate

    Time frame: Up to 8 weeks post-intervention

    Analyze and compare the quality of embryos on day 3, 5 or 6 between two groups

  5. Embryo development rate

    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

Secondary outcomes

  1. Live Birth rates

    Time frame: Up to 24 months post-intervention

    Compare live Birth rate following the intervention in both groups

  2. Endocrine hormones including AMH

    Time frame: Up to 8 weeks post-intervention

    Changes in endocrine hormones including AMH levels in serum after the interventions.

  3. Average egg retrieval capacity per person

    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.

  4. Additional in vitro fertilization - outcome indicators

    Time frame: Up to 8 weeks post-intervention

    Number of average recruited MII oocytes in both groups

  5. Chemical pregnancy rate

    Time frame: Up to 12months post-intervention

    Compare the chemical pregnancy rates between the two groups.

  6. Pregnancy complication

    Time frame: Up to 24 months post-intervention

    Rate of pregnancy complication in both groups

  7. Abortion rate

    Time frame: Up to 24 months post-intervention

    Compare the abortion rates in both groups

  8. Additional in vitro fertilization - outcome indicators

    Time frame: Up to 8 weeks post-intervention

    Compare the rate of fertilization in between two groups

  9. Additional in vitro fertilization - outcome indicators

    Time frame: Up to 8 weeks post-intervention

    Rate of abnormal fertilization in both groups

  10. Additional in vitro fertilization - outcome indicators

    Time frame: Up to 8 weeks post-intervention

    The rate of non-transferable embryos in both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Masaya Y., Masaya Yamanaka, BSc

CONTACT

[email protected]

+81 80 4344 2654

Udayanga KGS., Udayanga Gamage, BVSc, PhD

CONTACT

[email protected]

+81 90 9823 8477

Sponsors and collaborators

Lead sponsor

Sunkaky Medical Cooperation

Industry

Collaborators

  • Aba Chemicals Co Ltd
  • Abinopharm, Inc

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

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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