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

Not Applicable

Recruiting

• Conditions: Diminished Ovarian Reserve
• Interventions: Dietary Supplement: NMN; Other: Placebo

• Registration Number: NCT06426355
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-01
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Primary Completion: 2026-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMN intervention	NMN	Dietary Supplement: NMN intervention NMN capsules (total of 600mg/day) for 2-5 months
Placebo intervention	Placebo	Placebo NMN-free placebo capsules for 2-5 months

Primary Outcome Measures

Name	Time	Method
The clinical pregnancy rate	through study completion, an average of 2 year	The pregnancy rate of IVF/ICSI-ET

Secondary Outcome Measures

Name	Time	Method
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	Number of oocytes obtained, number of MII oocytes, fertilization rate, number of available embryos, number of high-quality embryos, cycle cancellation rate
Metabolism-related index	Within three months after the end of treatment with NMN or placebo	BMI
live birth rate	after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo	live birth rate
abortion rate	after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo	abortion rate
Endocrine hormones including AMH	Within three months after the end of treatment with NMN or placebo	Changes in endocrine hormones including AMH levels in serum after the intervention.
Follicle number	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.
the condition of newborn births	after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo	the condition of newborn births
Biochemical pregnancy rate	after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo	Biochemical pregnancy rate
pregnancy complications	after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo	pregnancy complications, the condition of newborn births

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China