Diminished Ovarian ReserveNCT05485610
Effect of NMN (Nicotinamide Mononucleotide) on Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)
A study testing NMN intervention in people with Diminished Ovarian Reserve and Premature Ovarian Insufficiency, 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 (including premature ovarian insufficiency). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve, Premature Ovarian Insufficiency
- What is being tested?
- NMN intervention
- 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 Jul 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
- The concentrations of anti-Mullerian hormone < 1.1 ng/ml, the values of antral follicle count range from less than 5 to less than 7 and two recordings of serum concentrations of day-3 follicle-stimulating hormone (FSH) ≥10 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jie Qiao, Ph.D., +86 010-82265080, jie.qiao@263.net
Jie Qiao, Ph.D.
About this study
Official title: Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)
The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve (including premature ovarian insufficiency).
Read the detailed description
This study aims to evaluate the effects of NMN on reproductive endocrine, immune homeostasis, and reproductive outcomes in women with DOR (including POI), and to explore its underlying mechanisms to provide the intervention strategies for DOR (including POI).
- Being tested
- NMN intervention, Placebo
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMN interventionDietary supplement
NMN capsules (total of 600mg/day) for 3 months
PlaceboOther
NMN-free placebo capsules for 3 months
| Study group | Role | What they receive |
|---|---|---|
| NMN intervention | Experimental | 3 months of NMN Receives: Dietary Supplement: NMN intervention |
| Placebo | Placebo comparator | 3 months of NMN-free placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of the gut microbiota composition
Determination the gut microbiota composition change of stool samples between placebo group and intervention group by 16S metagenomic.
Measured: before and after 2, 8, 12 weeks of intervention
The alterations of gut metabolites
Determination the alterations of gut metabolites before and after NMN intervention by metabolomics.
Measured: before and after 2, 8, 12 weeks of intervention
Blood sugar level
Changes in plasma glucose concentration after the intervention.
Measured: before and after 2, 8, 12 weeks of intervention
Fasting insulin
Changes in plasma insulin concentration after the intervention.
Measured: before and after 2, 8, 12 weeks of intervention
Endocrine hormones including AMH
Changes in endocrine hormones including AMH levels in serum after the intervention.
Measured: before and after 3 months of intervention
Ovarian volume
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Measured: before and after 3 months of intervention
Follicle number
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Measured: before and after 3 months of intervention
Blood NAD+ level
Changes in whole blood NAD+ level after the intervention.
Measured: before and after 2, 8, 12 weeks of intervention
Changes in NAD-related metabolites in urine
Determination the changes of NAD-related metabolites in urine before and after NMN intervention by metabolomics.
Measured: before and after 2, 8, 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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
- NCT05485610
- Sponsor's protocol ID
- M2022262
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 12 Oct 2022
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)
- ClinicalTrials.gov ID
- NCT05485610
- Acronym / sponsor ID
- M2022262
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Aug 2022 (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 (including premature ovarian insufficiency).
Detailed description
This study aims to evaluate the effects of NMN on reproductive endocrine, immune homeostasis, and reproductive outcomes in women with DOR (including POI), and to explore its underlying mechanisms to provide the intervention strategies for DOR (including POI).
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 | Experimental | Dietary Supplement: NMN intervention3 months of NMN |
| Placebo | Placebo comparator | Other: Placebo3 months of NMN-free placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals who are 20 to 40 years old.
- The concentrations of anti-Mullerian hormone < 1.1 ng/ml, the values of antral follicle count range from less than 5 to less than 7 and two recordings of serum concentrations of day-3 follicle-stimulating hormone (FSH) ≥10 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.
Key exclusion criteria (16 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 |
|---|---|---|
| NMN interventionNMN capsules (total of 600mg/day) for 3 months | Dietary supplement | NMN intervention |
| PlaceboNMN-free placebo capsules for 3 months | Other | Placebo |
Primary outcome
The comparison of the gut microbiota composition
Time frame: before and after 2, 8, 12 weeks of intervention
Determination the gut microbiota composition change of stool samples between placebo group and intervention group by 16S metagenomic.
The alterations of gut metabolites
Time frame: before and after 2, 8, 12 weeks of intervention
Determination the alterations of gut metabolites before and after NMN intervention by metabolomics.
Blood sugar level
Time frame: before and after 2, 8, 12 weeks of intervention
Changes in plasma glucose concentration after the intervention.
Fasting insulin
Time frame: before and after 2, 8, 12 weeks of intervention
Changes in plasma insulin concentration after the intervention.
Endocrine hormones including AMH
Time frame: before and after 3 months of intervention
Changes in endocrine hormones including AMH levels in serum after the intervention.
Ovarian volume
Time frame: before and after 3 months of intervention
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Follicle number
Time frame: before and after 3 months of intervention
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Blood NAD+ level
Time frame: before and after 2, 8, 12 weeks of intervention
Changes in whole blood NAD+ level after the intervention.
Changes in NAD-related metabolites in urine
Time frame: before and after 2, 8, 12 weeks of intervention
Determination the changes of NAD-related metabolites in urine before and after NMN intervention by metabolomics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- 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. This study is not recruiting at the moment.
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 intervention in people with Diminished Ovarian Reserve and Premature Ovarian Insufficiency, 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of the gut microbiota composition (time frame: before and after 2, 8, 12 weeks of intervention). The study lists 9 primary outcomes in all. 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 12 Oct 2022.