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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diminished Ovarian Reserve
• Intervention / Treatment: Dietary supplement: NMN; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengyu Liu, PhD; Phone Number: 15611555481; Email: myl1995lmy@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Peking University Third Hospital
      • Contact: Jie Qiao; Phone Number: 010-82265080; Email: jie.qiao@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NMN intervention; Dietary Supplement: NMN intervention NMN capsules (total of 600mg/day) for 2-5 months	Dietary supplement: NMN; NMN capsules (total of 600mg/day) for 2-5 months
Placebo Comparator: Placebo intervention; Placebo NMN-free placebo capsules for 2-5 months	Other: Placebo; NMN-free placebo capsules for 2-5 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinical pregnancy rate	The pregnancy rate of IVF/ICSI-ET	through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: M2023557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients' information is requested to be confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No