The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR

Diminished Ovarian Reserve Clinical Trial

Official title:

The Effeciency of Nicotinamide Mononucleotide (NMN) in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With Decreased Ovarian Reserve（DOR): a Randomized Double-blind Placebo Control Clinical Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426355
• Other study ID #: M2023557
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: February 2027

Study information

• Verified date: January 2024
• Source: Peking University Third Hospital
• Contact: Mengyu Liu, PhD
• Phone: 15611555481
• Email: myl1995lmy[@]163.com
• Is FDA regulated: No
• 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 and the outcomes of IVF/ICSI-ET.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2027
• Est. primary completion date: February 2026
• 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. 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.

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Related Conditions & MeSH terms

• Diminished Ovarian Reserve

Intervention

Dietary Supplement:
• NMN
NMN capsules (total of 600mg/day) for 2-5 months

Other:
• Placebo
NMN-free placebo capsules for 2-5 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 clinical pregnancy rate	The pregnancy rate of IVF/ICSI-ET	through study completion, an average of 2 year
Secondary	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
Secondary	Follicle number	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
Secondary	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
Secondary	Biochemical pregnancy rate	Biochemical pregnancy rate	after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo
Secondary	live birth rate	live birth rate	after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
Secondary	abortion rate	abortion rate	after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo
Secondary	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
Secondary	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
Secondary	Metabolism-related index	Intestinal flora and metabolite changes	Within three months after the end of treatment with NMN or placebo
Secondary	Metabolism-related index	HOMA index	Within three months after the end of treatment with NMN or placebo
Secondary	Metabolism-related index	waist-hip ratio	Within three months after the end of treatment with NMN or placebo
Secondary	Metabolism-related index	BMI	Within three months after the end of treatment with NMN or placebo