Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Location status: Recruiting
NCT Number: NCT06426355
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.
Interested in participating?
Request Info20 year–40 year
Female
Interventional
Not applicable
Beijing, Beijing Municipality, 100000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals who had pelvic surgery.
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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NMN capsules (total of 600mg/day) for 2-5 months
NMN-free placebo capsules for 2-5 months
Time frame: through study completion, an average of 2 year
The pregnancy rate of IVF/ICSI-ET
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.
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.
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
Time frame: after pregnancy and infant borned. Within 1 year 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, 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
Time frame: Within three months after the end of treatment with NMN or placebo
Intestinal flora and metabolite changes
Time frame: Within three months after the end of treatment with NMN or placebo
HOMA index
Time frame: Within three months after the end of treatment with NMN or placebo
waist-hip ratio
Time frame: Within three months after the end of treatment with NMN or placebo
BMI
Contact information is provided by the study sponsor or research team.
Peking University Third Hospital
Other
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
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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