Diminished Ovarian Reserve
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTNMN
NMN capsules (total of 600mg/day) for 2-5 months
OTHERPlacebo
NMN-free placebo capsules for 2-5 months
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals who are 20 to 40 years old. 2. At least two of the following three conditions should be met: 1. The concentrations of anti-Mullerian hormone \< 1.1 ng/ml, 2. the values of antral follicle count was less than 7 3. serum concentrations of day-3 follicle-stimulating hormone (FSH)： 10 IU/L ≤ FSH\<20 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. Individuals who had pelvic surgery. 3. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years. 4. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 5. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 6. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months. 7. 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. 8. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months. 9. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 10. A medical history of severe cardiovascular and cerebrovascular diseases. 11. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 12. Individuals who drink more than 15g of alcohol per day or have a smoking habit. 13. Individuals who need drug treatment for any mental illness such as epilepsy and depression. 14. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. 15. 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clinical pregnancy rate | through study completion, an average of 2 year | The pregnancy rate of IVF/ICSI-ET |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follicle number | Within three months after the end of treatment with NMN or placebo | The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant. |
| In vitro fertilization - outcome indicators of embryo culture | Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo | Number of oocytes obtained, number of MII oocytes, fertilization rate, number of available embryos, number of high-quality embryos, cycle cancellation rate |
| Biochemical pregnancy rate | after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo | Biochemical pregnancy rate |
| live birth rate | after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo | live birth rate |
| Endocrine hormones including AMH | Within three months after the end of treatment with NMN or placebo | Changes in endocrine hormones including AMH levels in serum after the intervention. |
| pregnancy complications | after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo | pregnancy complications, 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 | the condition of newborn births |
| Metabolism-related index | Within three months after the end of treatment with NMN or placebo | Intestinal flora and metabolite changes |
| abortion rate | after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo | abortion rate |
Countries
China
Contacts
Primary ContactMengyu Liu, PhD
Outcome results
None listed