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

NCT06629636 | Recruiting DMC

• 1 other identifier: IVFJapan202402
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Repeated IVF Failure; Female Infertility

Keywords

IVF failure; NMN; Female Infertility; Japan; Oocyte Mitochondria; Anti aging

Outcome Measures

Primary Outcomes (5)

• Embryo development rate

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

  Up to 8 weeks post-intervention

• Changes in metabolic status

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

  Up to 8 weeks post-intervention

• Clinical pregnancy rate

  Compare ongoing clinical pregnancy rates between NMN and placebo groups

  Up to 12months post-intervention

• Embryo development rate

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

  Up to 8 weeks post-intervention

• Embryo development rate

  Analyze and compare the rate of blastocyst development on day 5 and 6 in between two groups

  Up to 8 weeks post-intervention

Secondary Outcomes (10)

• 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

• Additional in vitro fertilization - outcome indicators

  Up to 8 weeks post-intervention

• Chemical pregnancy rate

  Up to 12months post-intervention

Study Arms (2)

NMN intervention

ACTIVE COMPARATOR

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

Dietary Supplement: NMN capsule

Placebo intervention

PLACEBO COMPARATOR

NMN-free placebo capsules for 8 weeks

Other: Placebo

Interventions

NMN capsule DIETARY_SUPPLEMENT

Total of 900mg/day for 8 weeks

NMN intervention

Placebo OTHER

NMN-free placebo capsules for 8 weeks

Placebo intervention

Eligibility Criteria

• Age: 32 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Agree to participate in the study
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunkaky Medical Cooperation: lead
• Abinopharm, Inc: collaborator
• Aba Chemicals Co Ltd: collaborator

Study Sites (1)

IVF Namba Clinic, Sankaky Medical Corporation

Osaka, Osaka, 5500015, Japan

RECRUITING

Related Publications (7)

• Huang H. A Multicentre, Randomised, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults. Front Aging. 2022 May 5;3:851698. doi: 10.3389/fragi.2022.851698. eCollection 2022.

  PMID: 35821806 BACKGROUND

• Yi L, Maier AB, Tao R, Lin Z, Vaidya A, Pendse S, Thasma S, Andhalkar N, Avhad G, Kumbhar V. The efficacy and safety of beta-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial. Geroscience. 2023 Feb;45(1):29-43. doi: 10.1007/s11357-022-00705-1. Epub 2022 Dec 8.

  PMID: 36482258 BACKGROUND

• Miao Y, Cui Z, Gao Q, Rui R, Xiong B. Nicotinamide Mononucleotide Supplementation Reverses the Declining Quality of Maternally Aged Oocytes. Cell Rep. 2020 Aug 4;32(5):107987. doi: 10.1016/j.celrep.2020.107987.

  PMID: 32755581 BACKGROUND

• Bertoldo MJ, Listijono DR, Ho WJ, Riepsamen AH, Goss DM, Richani D, Jin XL, Mahbub S, Campbell JM, Habibalahi A, Loh WN, Youngson NA, Maniam J, Wong ASA, Selesniemi K, Bustamante S, Li C, Zhao Y, Marinova MB, Kim LJ, Lau L, Wu RM, Mikolaizak AS, Araki T, Le Couteur DG, Turner N, Morris MJ, Walters KA, Goldys E, O'Neill C, Gilchrist RB, Sinclair DA, Homer HA, Wu LE. NAD+ Repletion Rescues Female Fertility during Reproductive Aging. Cell Rep. 2020 Feb 11;30(6):1670-1681.e7. doi: 10.1016/j.celrep.2020.01.058.

  PMID: 32049001 BACKGROUND

• Schultz MB, Sinclair DA. Why NAD(+) Declines during Aging: It's Destroyed. Cell Metab. 2016 Jun 14;23(6):965-966. doi: 10.1016/j.cmet.2016.05.022.

  PMID: 27304496 BACKGROUND

• Bentov Y, Yavorska T, Esfandiari N, Jurisicova A, Casper RF. The contribution of mitochondrial function to reproductive aging. J Assist Reprod Genet. 2011 Sep;28(9):773-83. doi: 10.1007/s10815-011-9588-7. Epub 2011 May 27.

  PMID: 21617930 BACKGROUND

• Hashimoto S, Morimoto Y. Mitochondrial function of human embryo: Decline in their quality with maternal aging. Reprod Med Biol. 2022 Dec 21;21(1):e12491. doi: 10.1002/rmb2.12491. eCollection 2022 Jan-Dec.

  PMID: 36570768 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Yoshiharu M., Yoshiharu Morimoto, MD, PhD

  Sankaky Medical Corporation

  PRINCIPAL INVESTIGATOR

• Naoharu M., Naoharu Yoshiharu, MD

  Sankaky Medical Corporation

  STUDY DIRECTOR

Central Study Contacts

Udayanga KGS., Udayanga Gamage, BVSc, PhD

CONTACT

+81 90 9823 8477; udayanga646@ivfjapan.com

Masaya Y., Masaya Yamanaka, BSc

CONTACT

+81 80 4344 2654; yamanaka086@ivfjapan.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dietary Supplement: NMN intervention NMN capsules (total of 900mg/day) for 8 weeks, NMN capsules (total of 900mg/day) for 8 weeks Placebo Comparator: Placebo intervention Placebo NMN-free placebo capsules for 8 weeks Other: Placebo, for 8 weeks

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: August 20, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)