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NCT Number: NCT06426355

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

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.

Recruiting

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Jie Qiao

CONTACT

[email protected]

010-82265080

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

NMN

Dietary Supplement

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

Placebo

Other

NMN-free placebo capsules for 2-5 months

Primary outcomes

  1. The clinical pregnancy rate

    Time frame: through study completion, an average of 2 year

    The pregnancy rate of IVF/ICSI-ET

Secondary outcomes

  1. Endocrine hormones including AMH

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

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

  2. Follicle number

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

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

  3. 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

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

  4. Biochemical pregnancy rate

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

    Biochemical pregnancy rate

  5. live birth rate

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

    live birth rate

  6. abortion rate

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

    abortion rate

  7. pregnancy complications

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

    pregnancy complications, the condition of newborn births

  8. the condition of newborn births

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

    the condition of newborn births

  9. Metabolism-related index

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

    Intestinal flora and metabolite changes

  10. Metabolism-related index

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

    HOMA index

  11. Metabolism-related index

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

    waist-hip ratio

  12. Metabolism-related index

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

    BMI

Study contacts

Contact information is provided by the study sponsor or research team.

Mengyu Liu, PhD

CONTACT

[email protected]

15611555481

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 23, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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