Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05485610
Other study ID # M2022262
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2025

Study information

Verified date June 2022
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: 1. Individuals who are 20 to 40 years old. 2. 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. 3. Individuals who can insist on continuous monitoring in the outpatient clinic. 4. Individuals who are not participating in other research projects currently or 3 months before the intervention. Exclusion Criteria: 1. Individuals who are during pregnant, lactation or menopause. 2. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology. 3. Individuals who had pelvic surgery. 4. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years. 5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 6. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 7. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months. 8. 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. 9. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months. 10. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 11. A medical history of severe cardiovascular and cerebrovascular diseases. 12. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 13. Individuals who drink more than 15g of alcohol per day or have a smoking habit. 14. Individuals who need drug treatment for any mental illness such as epilepsy and depression. 15. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. 16. Unable or unwilling to follow the study protocol.

Study Design


Intervention

Dietary Supplement:
NMN intervention
NMN capsules (total of 600mg/day) for 3 months
Other:
Placebo
NMN-free placebo capsules for 3 months

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. before and after 2, 8, 12 weeks of intervention
Primary The alterations of gut metabolites Determination the alterations of gut metabolites before and after NMN intervention by metabolomics. before and after 2, 8, 12 weeks of intervention
Primary Blood sugar level Changes in plasma glucose concentration after the intervention. before and after 2, 8, 12 weeks of intervention
Primary Fasting insulin Changes in plasma insulin concentration after the intervention. before and after 2, 8, 12 weeks of intervention
Primary Endocrine hormones including AMH Changes in endocrine hormones including AMH levels in serum after the intervention. before and after 3 months of intervention
Primary Ovarian volume The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase. before and after 3 months of intervention
Primary Follicle number The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant. before and after 3 months of intervention
Primary Blood NAD+ level Changes in whole blood NAD+ level after the intervention. before and after 2, 8, 12 weeks of intervention
Primary Changes in NAD-related metabolites in urine Determination the changes of NAD-related metabolites in urine before and after NMN intervention by metabolomics. before and after 2, 8, 12 weeks of intervention
See also
  Status Clinical Trial Phase
Recruiting NCT04972877 - Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve N/A
Recruiting NCT04447872 - The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol N/A
Recruiting NCT05277948 - Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR) N/A
Recruiting NCT04711772 - Whole-genome Sequencing Study in Patients With Diminished Ovarian Reserve
Recruiting NCT03670407 - Follicular Activation by Fragmentation of Ovarian Tissue N/A
Recruiting NCT06072794 - A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI) Phase 1
Recruiting NCT06096766 - the Correlation Between Ovarian Function and Serum Biomarkers
Not yet recruiting NCT02099916 - Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF Phase 2/Phase 3
Not yet recruiting NCT06081257 - The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve N/A
Recruiting NCT06426355 - The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR N/A
Recruiting NCT04275700 - Study of PRP in Women With Evidence of Diminished Ovarian Reserve N/A
Recruiting NCT06223178 - Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve N/A
Not yet recruiting NCT05577455 - Efficacy of Traditional Chinese Medicine on Ameliorating IVF-ET Outcomes of Diminished Ovarian Reserve Patients Phase 3
Not yet recruiting NCT05459493 - A Clinical Study of Chinese Herbal Compound TJAOA101 in Therapy of Diminished Ovarian Reserve Early Phase 1
Recruiting NCT05665010 - Precise Stratification of Genetic Risk of Ovarian Function Impairment
Not yet recruiting NCT05385848 - Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study N/A
Terminated NCT01614067 - Delayed Start to Ovarian Stimulation Phase 4
Recruiting NCT06395623 - Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics
Recruiting NCT05847283 - DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT N/A
Completed NCT04237909 - Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency N/A