Using NMN to improve IVF outcomes in women with low ovarian reserve

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

This study is testing if a supplement called NMN can help improve pregnancy success rates for women with low ovarian reserve who are going through IVF.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06426355 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of nicotinamide mononucleotide (NMN) on improving pregnancy outcomes in patients undergoing IVF/ICSI-ET who have diminished ovarian reserve. Participants aged 20 to 40 will be given either NMN or a placebo to assess its impact on fertility markers and overall success rates of assisted reproductive technology. The study aims to provide insights into how NMN may enhance reproductive health in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are women aged 20 to 40 with specific hormonal and follicle count criteria indicating diminished ovarian reserve.

Not a fit: Patients who are pregnant, lactating, or in menopause, as well as those with certain genetic conditions or chronic diseases requiring regular medication, may not benefit from this study.

Why it matters

Potential benefit: If successful, this could lead to improved pregnancy rates for women with diminished ovarian reserve undergoing IVF treatments.

How similar studies have performed: While there is limited data on NMN specifically for this purpose, similar studies exploring interventions for improving IVF outcomes in patients with diminished ovarian reserve have shown promise.

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.

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Where this trial is running

Beijing, Beijing Municipality

• Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Mengyu Liu, PhD

Conditions Diminished Ovarian Reserve