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The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve (including premature ovarian insufficiency).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMN intervention | Experimental | 3 months of NMN |
|
| Placebo | Placebo Comparator | 3 months of NMN-free placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMN intervention | Dietary Supplement | NMN capsules (total of 600mg/day) for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Blood sugar level | Changes in plasma glucose concentration after the intervention. | before and after 2, 8, 12 weeks of intervention |
| Fasting insulin | Changes in plasma insulin concentration after the intervention. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
Patients' information is requested to be confidential.
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| Placebo |
| Other |
NMN-free placebo capsules for 3 months |
|
| before and after 3 months of intervention |
| Blood NAD+ level | Changes in whole blood NAD+ level after the intervention. | 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. | before and after 2, 8, 12 weeks of intervention |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |