Actively Recruiting
The Efficiency 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 Trial
Led by Peking University Third Hospital · Updated on 2024-05-23
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of nicotinamide mononucleotide (NMN) on women aged 20 to 40 years with diminished ovarian reserve (DOR) undergoing IVF or ICSI-ET. This study aims to understand how NMN influences pregnancy outcomes, including clinical pregnancy rates, in this group. The trial is a randomized, double-blind, placebo-controlled clinical trial sponsored by Peking University Third Hospital. Participants are randomly assigned to one of two groups: one receiving NMN capsules at a total dose of 600 mg per day for 2 to 5 months, and the other receiving placebo capsules without NMN for the same duration. The study compares these interventions to assess their impact on IVF/ICSI-ET outcomes. Treatment duration and follow-up periods are carefully monitored. During the study, participants will undergo assessments including hormone levels (such as AMH and FSH), follicle counts, embryo culture outcomes, and metabolic indicators within three months after treatment. Pregnancy-related outcomes like biochemical pregnancy rate, live birth rate, abortion rate, pregnancy complications, and newborn conditions will be tracked for up to one year after treatment. The primary outcome measured is the clinical pregnancy rate over an average of two years. Participants must attend outpatient monitoring throughout the study period.
CONDITIONS
Brief Title
The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 20 to 40 years
- Meet at least two of the following: anti-Mullerian hormone less than 1.1 ng/ml, antral follicle count less than 7, or day-3 follicle-stimulating hormone between 10 and less than 20 IU/L
- Able to attend continuous outpatient clinic monitoring
- Not participating in other research projects currently or within 3 months prior to intervention
You will not qualify if you...
- Pregnant, breastfeeding, or menopausal individuals
- Non-46-XX karyotype or known genetic causes
- History of pelvic surgery
- Cancer patients or those who received chemo/radiotherapy in past 5 years
- Regular medication for chronic diseases like diabetes, hypertension, gout, or hyperuricemia
- Use of weight-loss drugs or surgery within past 2 months
- Use of medications or traditional Chinese medicine affecting hormones, appetite, carbohydrate absorption, or metabolism within past 3 months
- Use of niacin, nicotinamide, vitamin B3-related supplements, coenzyme Q10, or vitamin E within past 3 months
- Use of antibiotics, probiotics, or prebiotics affecting flora within past 3 months
- Severe liver or kidney disease
- History of severe cardiovascular or cerebrovascular disease
- Severe gastrointestinal diseases or gastrointestinal resection affecting nutrient absorption
- Consuming more than 15g alcohol per day or smoking
- Need for drug treatment for mental illnesses such as epilepsy or depression
- Infectious diseases like hepatitis B, active tuberculosis, or AIDS
- Unable or unwilling to follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 5 months
Participants receive NMN capsules or placebo capsules daily for 2 to 5 months.
Regular outpatient visits during treatment
Duration - Up to 1 year
Participants are monitored for pregnancy outcomes and other health indicators for up to 1 year after treatment ends.
Follow-up visits within 3 months and up to 1 year after treatment
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
M
Mengyu Liu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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