## Protocol Section
### Identification Module
**NCT ID:** NCT06426355

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

**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

#### Organization Study ID Info
**ID:** M2023557
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2027-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University Third Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diminished Ovarian Reserve

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Dietary Supplement: NMN

**Label:** NMN intervention

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Placebo NMN-free placebo capsules for 2-5 months

**Intervention Names:**

- Other: Placebo

**Label:** Placebo intervention

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- NMN intervention

**Description:** NMN capsules (total of 600mg/day) for 2-5 months

**Name:** NMN

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo intervention

**Description:** NMN-free placebo capsules for 2-5 months

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The pregnancy rate of IVF/ICSI-ET

**Measure:** The clinical pregnancy rate

**Time Frame:** through study completion, an average of 2 year

#### Secondary Outcomes

**Description:** Changes in endocrine hormones including AMH levels in serum after the intervention.

**Measure:** Endocrine hormones including AMH

**Time Frame:** Within three months after the end of treatment with NMN or placebo

**Description:** The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.

**Measure:** Follicle number

**Time Frame:** Within three months after the end of treatment with NMN or placebo

**Description:** Number of oocytes obtained, number of MII oocytes, fertilization rate, number of available embryos, number of high-quality embryos, cycle cancellation rate

**Measure:** In vitro fertilization - outcome indicators of embryo culture

**Time Frame:** Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo

**Description:** Biochemical pregnancy rate

**Measure:** Biochemical pregnancy rate

**Time Frame:** after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo

**Description:** live birth rate

**Measure:** live birth rate

**Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo

**Description:** abortion rate

**Measure:** abortion rate

**Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo

**Description:** pregnancy complications, the condition of newborn births

**Measure:** pregnancy complications

**Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo

**Description:** the condition of newborn births

**Measure:** the condition of newborn births

**Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo

**Description:** Intestinal flora and metabolite changes

**Measure:** Metabolism-related index

**Time Frame:** Within three months after the end of treatment with NMN or placebo

**Description:** HOMA index

**Measure:** Metabolism-related index

**Time Frame:** Within three months after the end of treatment with NMN or placebo

**Description:** waist-hip ratio

**Measure:** Metabolism-related index

**Time Frame:** Within three months after the end of treatment with NMN or placebo

**Description:** BMI

**Measure:** Metabolism-related index

**Time Frame:** Within three months after the end of treatment with NMN or placebo

### Eligibility Module

**Eligibility Criteria:** 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.

-

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** myl1995lmy@163.com

**Name:** Mengyu Liu, PhD

**Phone:** 15611555481

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** jie.qiao@263.net

- **Name:** Jie Qiao

- **Phone:** 010-82265080

- **Role:** CONTACT

**Country:** China

**Facility:** Peking University Third Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100000

### IPD Sharing Statement Module

**Description:** Patients' information is requested to be confidential.

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M12476

- Name: Niacinamide

- Relevance: LOW

- As Found: Unknown

- ID: M12465

- Name: Niacin

- Relevance: LOW

- As Found: Unknown

- ID: M12479

- Name: Nicotinic Acids

- Relevance: LOW

- As Found: Unknown

- ID: T455

- Name: Nicotinamide

- Relevance: LOW

- As Found: Unknown

- ID: T453

- Name: Niacin

- Relevance: LOW

- As Found: Unknown

- ID: T454

- Name: Niacinamide

- Relevance: LOW

- As Found: Unknown

- ID: T456

- Name: Nicotinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T471

- Name: Vitamin B3

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
