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Recruiting NCT06426355

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

No phase Interventional Diminished Ovarian Reserve

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NMN, Placebo.
Who it may be relevant to
Registry conditions: Diminished Ovarian Reserve. Basic parameters: 20 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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 supplement NMN
    NMN capsules (total of 600mg/day) for 2-5 months
  • Other Placebo
    NMN-free placebo capsules for 2-5 months

Primary outcome measures

  • The clinical pregnancy rate [Time frame: through study completion, an average of 2 year]
Secondary outcome measures (12)
  • Endocrine hormones including AMH [Time frame: Within three months after the end of treatment with NMN or placebo]
  • Follicle number [Time frame: Within three months after the end of treatment with NMN or placebo]
  • 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]
  • Biochemical pregnancy rate [Time frame: after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo]
  • live birth rate [Time frame: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo]
  • abortion rate [Time frame: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo]
  • pregnancy complications [Time frame: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo]
  • the condition of newborn births [Time frame: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo]
  • Metabolism-related index [Time frame: Within three months after the end of treatment with NMN or placebo]
  • Metabolism-related index [Time frame: Within three months after the end of treatment with NMN or placebo]
  • Metabolism-related index [Time frame: Within three months after the end of treatment with NMN or placebo]
  • Metabolism-related index [Time frame: Within three months after the end of treatment with NMN or placebo]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT06426355 · M2023557

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗