Diminished Ovarian ReserveNCT06426355
The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR
A study testing NMN in people with Diminished Ovarian Reserve, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve and the outcomes of IVF/ICSI-ET. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- NMN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to Feb 2027
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who are 20 to 40 years old.
- At least two of the following three conditions should be met:
- The concentrations of anti-Mullerian hormone < 1.1 ng/ml,
- the values of antral follicle count was less than 7
- serum concentrations of day-3 follicle-stimulating hormone (FSH)： 10 IU/L ≤ FSH<20 IU/L
- Individuals who can insist on continuous monitoring in the outpatient clinic.
- Individuals who are not participating in other research projects currently or 3 months before the intervention.
Who cannot join
- Individuals who are during pregnant, lactation or menopause.
- Individuals who had non-46-XX karyotype, or attributed to known genetic etiology.
- Individuals who had pelvic surgery.
- Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years.
- Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
- Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
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- Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months.
- Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months.
- Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months.
- Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
- A medical history of severe cardiovascular and cerebrovascular diseases.
- Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
- Individuals who drink more than 15g of alcohol per day or have a smoking habit.
- 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.
- Unable or unwilling to follow the study protocol.
- Individuals who are during pregnant, lactation or menopause. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology.
- Individuals who had pelvic surgery. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years.
- Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
- Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
- Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months.
- Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months.
- Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months.
- Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
- A medical history of severe cardiovascular and cerebrovascular diseases. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
- Individuals who drink more than 15g of alcohol per day or have a smoking habit. 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.
- Unable or unwilling to follow the study protocol.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Jie Qiao, 010-82265080, jie.qiao@263.net
About this study
Official title: The Effeciency of Nicotinamide Mononucleotide (NMN) in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With Decreased Ovarian Reserve（DOR): a Randomized Double-blind Placebo Control Clinical Trail
The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve and the outcomes of IVF/ICSI-ET.
- Conditions
- Diminished Ovarian Reserve
- Being tested
- NMN, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMNDietary supplement
NMN capsules (total of 600mg/day) for 2-5 months
PlaceboOther
NMN-free placebo capsules for 2-5 months
| Study group | Role | What they receive |
|---|---|---|
| NMN intervention | Active comparator | Dietary Supplement: NMN intervention NMN capsules (total of 600mg/day) for 2-5 months Receives: Dietary Supplement: NMN |
| Placebo intervention | Placebo comparator | Placebo NMN-free placebo capsules for 2-5 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical pregnancy rate
The pregnancy rate of IVF/ICSI-ET
Measured: through study completion, an average of 2 year
Secondary outcomes (12)
Endocrine hormones including AMH
Changes in endocrine hormones including AMH levels in serum after the intervention.
Measured: Within three months after the end of treatment with NMN or placebo
Follicle number
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Measured: Within three months after the end of treatment with NMN or placebo
In vitro fertilization - outcome indicators of embryo culture
Number of oocytes obtained, number of MII oocytes, fertilization rate, number of available embryos, number of high-quality embryos, cycle cancellation rate
Measured: Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo
Biochemical pregnancy rate
Biochemical pregnancy rate
Measured: after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo
live birth rate
live birth rate
Measured: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
abortion rate
abortion rate
Measured: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
pregnancy complications
pregnancy complications, the condition of newborn births
Measured: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
the condition of newborn births
the condition of newborn births
Measured: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
Metabolism-related index
Intestinal flora and metabolite changes
Measured: Within three months after the end of treatment with NMN or placebo
Metabolism-related index
HOMA index
Measured: Within three months after the end of treatment with NMN or placebo
Metabolism-related index
waist-hip ratio
Measured: Within three months after the end of treatment with NMN or placebo
Metabolism-related index
BMI
Measured: Within three months after the end of treatment with NMN or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Oct 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426355
- Sponsor's protocol ID
- M2023557
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients' information is requested to be confidential.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effeciency of Nicotinamide Mononucleotide (NMN) in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With Decreased Ovarian Reserve（DOR): a Randomized Double-blind Placebo Control Clinical Trail
- ClinicalTrials.gov ID
- NCT06426355
- Acronym / sponsor ID
- M2023557
- Conditions
- Diminished Ovarian Reserve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 23 May 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 purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve and the outcomes of IVF/ICSI-ET.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMN intervention | Active comparator | Dietary Supplement: NMNDietary Supplement: NMN intervention NMN capsules (total of 600mg/day) for 2-5 months |
| Placebo intervention | Placebo comparator | Other: PlaceboPlacebo NMN-free placebo capsules for 2-5 months |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals who are 20 to 40 years old.
- At least two of the following three conditions should be met:
- Individuals who can insist on continuous monitoring in the outpatient clinic.
- Individuals who are not participating in other research projects currently or 3 months before the intervention.
Key exclusion criteria (29 listed)
- Individuals who are during pregnant, lactation or menopause.
- Individuals who had non-46-XX karyotype, or attributed to known genetic etiology.
- Individuals who had pelvic surgery.
- Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years.
- Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
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 |
|---|---|---|
| NMNNMN capsules (total of 600mg/day) for 2-5 months | Dietary supplement | NMN intervention |
| PlaceboNMN-free placebo capsules for 2-5 months | Other | Placebo intervention |
Primary outcome
The clinical pregnancy rate
Time frame: through study completion, an average of 2 year
The pregnancy rate of IVF/ICSI-ET
12 secondary outcomes
Endocrine hormones including AMH
Time frame: Within three months after the end of treatment with NMN or placebo
Follicle number
Time frame: Within three months after the end of treatment with NMN or placebo
In vitro fertilization - outcome indicators of embryo culture
Time frame: Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo
Biochemical pregnancy rate
Time frame: after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo
live birth rate
Time frame: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
abortion rate
Time frame: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
pregnancy complications
Time frame: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
the condition of newborn births
Time frame: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
Metabolism-related index
Time frame: Within three months after the end of treatment with NMN or placebo
Metabolism-related index
Time frame: Within three months after the end of treatment with NMN or placebo
Metabolism-related index
Time frame: Within three months after the end of treatment with NMN or placebo
Metabolism-related index
Time frame: Within three months after the end of treatment with NMN or placebo
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 23 May 2024.
- Individual participant dataSharing planned: No. Patients' information is requested to be confidential.
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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.
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 in people with Diminished Ovarian Reserve, run by Peking University Third Hospital at 1 site in China.
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 7 inclusion and 29 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 23 May 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 China. 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 Mengyu Liu, PhD (15611555481, myl1995lmy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical pregnancy rate (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2024.