Repeated IVF FailureNCT06629636
Investigate the Efficacy of Using NMN to Improve Embryo Development Capacity.
A study testing NMN capsule in people with Repeated IVF Failure and Female Infertility, run by Sunkaky Medical Cooperation at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 42 years, women only
- Conditions the study is for
- Repeated IVF Failure, Female Infertility
- What is being tested?
- NMN capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 20 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
IVF Namba Clinic, Sankaky Medical Corporation
Osaka, Osaka, 5500015
Naoharu M., Naoharu Morimoto, MD, +81 6 6534 8824, morimoto003@ivfjapan.com
About this study
Official title: Investigate the Efficacy of Using NMN to Improve Embryo Development Capacity and IVF Success Rate in Patients Who Have Experienced IVF Failures.
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.
Read the detailed description
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.
- Conditions
- Repeated IVF Failure, Female Infertility
- Being tested
- NMN capsule, Placebo
- Keywords
- IVF failure, NMN, Female Infertility, Japan, Oocyte Mitochondria, Anti aging
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMN capsuleDietary supplement
Total of 900mg/day for 8 weeks
PlaceboOther
NMN-free placebo capsules for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| NMN intervention | Active comparator | NMN capsules (total of 900mg/day) for 8 weeks Receives: Dietary Supplement: NMN capsule |
| Placebo intervention | Placebo comparator | NMN-free placebo capsules for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo development rate
Analyze and compare the transferable embryo rate per zygote on day 3 in between NMN and placebo intervention groups.
Measured: 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
Measured: Up to 8 weeks post-intervention
Clinical pregnancy rate
Compare ongoing clinical pregnancy rates between NMN and placebo groups
Measured: Up to 12months post-intervention
Embryo development rate
Analyze and compare the quality of embryos on day 3, 5 or 6 between two groups
Measured: 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
Measured: Up to 8 weeks post-intervention
Secondary outcomes (10)
Live Birth rates
Compare live Birth rate following the intervention in both groups
Measured: Up to 24 months post-intervention
Endocrine hormones including AMH
Changes in endocrine hormones including AMH levels in serum after the interventions.
Measured: Up to 8 weeks post-intervention
Average egg retrieval capacity per person
Compare the number of antral follicles in each ovary will be determined using transvaginal ultrasonography in both groups.
Measured: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Number of average recruited MII oocytes in both groups
Measured: Up to 8 weeks post-intervention
Chemical pregnancy rate
Compare the chemical pregnancy rates between the two groups.
Measured: Up to 12months post-intervention
Pregnancy complication
Rate of pregnancy complication in both groups
Measured: Up to 24 months post-intervention
Abortion rate
Compare the abortion rates in both groups
Measured: Up to 24 months post-intervention
Additional in vitro fertilization - outcome indicators
Compare the rate of fertilization in between two groups
Measured: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Rate of abnormal fertilization in both groups
Measured: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
The rate of non-transferable embryos in both groups
Measured: Up to 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Aug 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Repeated IVF FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunkaky Medical Cooperation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abinopharm, Inc, Aba Chemicals Co Ltd
- Responsible party
- Sponsor
- Investigators
- Yoshiharu M., Yoshiharu Morimoto, MD, PhD, Principal investigator, Sankaky Medical CorporationNaoharu M., Naoharu Yoshiharu, MD, Study director, Sankaky Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629636
- Sponsor's protocol ID
- IVFJapan202402
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The confidentiality of patients' information is strictly maintained.
Publications
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.
PubMed 35821806Yi 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.
PubMed 36482258Miao 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.
PubMed 32755581Bertoldo 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.
PubMed 32049001Schultz 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.
PubMed 27304496Bentov 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.
PubMed 21617930Hashimoto 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.
PubMed 36570768
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Efficacy of Using NMN to Improve Embryo Development Capacity and IVF Success Rate in Patients Who Have Experienced IVF Failures.
- ClinicalTrials.gov ID
- NCT06629636
- Acronym / sponsor ID
- IVFJapan202402
- Conditions
- Repeated IVF Failure, Female Infertility
- Keywords
- IVF failure, NMN, Female Infertility, Japan, Oocyte Mitochondria, Anti aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunkaky Medical CooperationIndustry (pharma, biotech, devices)
- Collaborators
- Abinopharm, Inc, Aba Chemicals Co Ltd
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| NMN intervention | Active comparator | Dietary Supplement: NMN capsuleNMN capsules (total of 900mg/day) for 8 weeks |
| Placebo intervention | Placebo comparator | Other: PlaceboNMN-free placebo capsules for 8 weeks |
Who may qualify
- Ages
- 32 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMN capsuleTotal of 900mg/day for 8 weeks | Dietary supplement | NMN intervention |
| PlaceboNMN-free placebo capsules for 8 weeks | Other | Placebo intervention |
Primary outcome
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.
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
Clinical pregnancy rate
Time frame: Up to 12months post-intervention
Compare ongoing clinical pregnancy rates between NMN and placebo groups
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
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
10 secondary outcomes
Live Birth rates
Time frame: Up to 24 months post-intervention
Endocrine hormones including AMH
Time frame: Up to 8 weeks post-intervention
Average egg retrieval capacity per person
Time frame: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Time frame: Up to 8 weeks post-intervention
Chemical pregnancy rate
Time frame: Up to 12months post-intervention
Pregnancy complication
Time frame: Up to 24 months post-intervention
Abortion rate
Time frame: Up to 24 months post-intervention
Additional in vitro fertilization - outcome indicators
Time frame: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Time frame: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Time frame: Up to 8 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 35821806Huang 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.
- Results publication: PubMed 36482258Yi 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.
- Results publication: PubMed 32755581Miao 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.
- Results publication: PubMed 32049001Bertoldo 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.
- Results publication: PubMed 27304496Schultz 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.
- Results publication: PubMed 21617930Bentov 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.
- Results publication: PubMed 36570768Hashimoto 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.
- Individual participant dataSharing planned: No. The confidentiality of patients' information is strictly maintained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoshiharu M., Yoshiharu Morimoto, MD, PhD principal investigator
Sankaky Medical Corporation
Naoharu M., Naoharu Yoshiharu, MD study director
Sankaky Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMN capsule in people with Repeated IVF Failure and Female Infertility, run by Sunkaky Medical Cooperation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Udayanga KGS., Udayanga Gamage, BVSc, PhD (+81 90 9823 8477, udayanga646@ivfjapan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo development rate (time frame: Up to 8 weeks post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06629636, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.