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

NCT06426355 | Recruiting DMC

• 1 other identifier: M2023557
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Diminished Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• The clinical pregnancy rate

  The pregnancy rate of IVF/ICSI-ET

  through study completion, an average of 2 year

Secondary Outcomes (12)

• Endocrine hormones including AMH

  Within three months after the end of treatment with NMN or placebo

• Follicle number

  Within three months after the end of treatment with NMN or placebo

• 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

• Biochemical pregnancy rate

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

• live birth rate

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

Study Arms (2)

NMN intervention

ACTIVE COMPARATOR

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

Dietary Supplement: NMN

Placebo intervention

PLACEBO COMPARATOR

Placebo NMN-free placebo capsules for 2-5 months

Other: Placebo

Interventions

NMN DIETARY_SUPPLEMENT

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

NMN intervention

Placebo OTHER

NMN-free placebo capsules for 2-5 months

Placebo intervention

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who are 20 to 40 years old.
• At least two of the following three conditions should be met:
• The concentrations of anti-Mullerian hormone \< 1.1 ng/ml,
• the values of antral follicle count was less than 7
• serum concentrations of day-3 follicle-stimulating hormone (FSH)： 10 IU/L ≤ FSH\<20 IU/L
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

Mengyu Liu, PhD

CONTACT

15611555481; myl1995lmy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: May 23, 2024
• Study Start: October 1, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)