Идёт набор NCT06426355

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

Без фазы С лечением Diminished Ovarian Reserve

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: NMN, Placebo.
Кому может быть актуально: Состояния в реестре: Diminished Ovarian Reserve. Базовые параметры: 20 лет — 40 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Пищевая добавка NMN
NMN capsules (total of 600mg/day) for 2-5 months
Другое Placebo
NMN-free placebo capsules for 2-5 months

Первичные конечные точки

The clinical pregnancy rate [Срок оценки: through study completion, an average of 2 year]

Вторичные конечные точки (12)

Endocrine hormones including AMH [Срок оценки: Within three months after the end of treatment with NMN or placebo]
Follicle number [Срок оценки: Within three months after the end of treatment with NMN or placebo]
In vitro fertilization - outcome indicators of embryo culture [Срок оценки: Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo]
Biochemical pregnancy rate [Срок оценки: after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo]
live birth rate [Срок оценки: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo]
abortion rate [Срок оценки: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo]
pregnancy complications [Срок оценки: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo]
the condition of newborn births [Срок оценки: after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo]
Metabolism-related index [Срок оценки: Within three months after the end of treatment with NMN or placebo]
Metabolism-related index [Срок оценки: Within three months after the end of treatment with NMN or placebo]
Metabolism-related index [Срок оценки: Within three months after the end of treatment with NMN or placebo]
Metabolism-related index [Срок оценки: Within three months after the end of treatment with NMN or placebo]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет