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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMN intervention | Active Comparator | Dietary Supplement: NMN intervention NMN capsules (total of 600mg/day) for 2-5 months |
|
| Placebo intervention | Placebo Comparator | Placebo NMN-free placebo capsules for 2-5 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMN | Dietary Supplement | NMN capsules (total of 600mg/day) for 2-5 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The clinical pregnancy rate | The pregnancy rate of IVF/ICSI-ET | through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Endocrine hormones including AMH | Changes in endocrine hormones including AMH levels in serum after the intervention. | Within three months after the end of treatment with NMN or placebo |
| Follicle number |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengyu Liu, PhD | Contact | 15611555481 | myl1995lmy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
Patients' information is requested to be confidential.
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| Placebo |
| Other |
NMN-free placebo capsules for 2-5 months |
|
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
| 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 | 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 | after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo |
| live birth rate | live birth rate | after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo |
| abortion rate | abortion rate | 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 | 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 | 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 | Within three months after the end of treatment with NMN or placebo |
| Metabolism-related index | HOMA index | Within three months after the end of treatment with NMN or placebo |
| Metabolism-related index | waist-hip ratio | Within three months after the end of treatment with NMN or placebo |
| Metabolism-related index | BMI | Within three months after the end of treatment with NMN or placebo |