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Набор скоро начнётся NCT07581444

Early Prevention and Precision Management of Female Fertility Decline

Без фазы С лечением Female Fertility Decline Diminished Ovarian Reserve Reproductive Health Infertility Prevention

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: Comprehensive Lifestyle Intervention, Routine Clinical Care.
Кому может быть актуально
Состояния в реестре: Female Fertility Decline, Diminished Ovarian Reserve, Reproductive Health, Infertility Prevention. 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
Список центров уточняется — проверьте первичный протокол.
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

Development and Evaluation of a Precision Prevention Strategy for Early Female Fertility Decline Based on OvaRePred-Plus: A Multicenter Cluster Randomized Controlled Trial

Обзор

Female fertility decline has become an important public health issue in China, with a substantial proportion of women of reproductive age experiencing reduced ovarian reserve. However, effective tools for early identification and large-scale prevention of fertility impairment in the general population are still lacking. This study aims to develop and evaluate a precision prevention strategy for early female fertility decline based on the OvaRePred-Plus model, which integrates ovarian reserve markers, lifestyle factors, and reproductive health indicators. A multicenter, cluster randomized controlled trial will be conducted across six medical centers in China, enrolling women aged 20-40 years identified as having early signs of fertility decline. Participants will be allocated to either an intervention group receiving a comprehensive health management program (including dietary optimization, nutritional supplementation, physical activity, and sleep improvement) or a control group receiving routine clinical care. The intervention will last for 12 weeks. The primary outcome is the change in fertility score assessed by the OvaRePred-Plus model. Secondary outcomes include changes in ovarian reserve markers (e.g., AMH), menstrual status, ultrasound parameters, and reproductive outcomes. This study is expected to provide evidence for a scalable and cost-effective strategy for early prevention and management of female fertility decline.

Вмешательства

  • Поведенческое Comprehensive Lifestyle Intervention
    A 12-week structured lifestyle intervention program designed to improve female reproductive health. The intervention includes dietary optimization (high-protein, high-vitamin, low-fat diet), nutritional supplementation (vitamin C, vitamin D, and folic acid), structured physical activity (at least 150 minutes of moderate-intensity exercise per week), and sleep improvement (7-8 hours per night with optimized sleep timing). The program is supported by biweekly health education sessions and digital
  • Другое Routine Clinical Care
    Participants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program.

Первичные конечные точки

  • Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks [Срок оценки: Baseline to 12 weeks]
Вторичные конечные точки (3)
  • Change in Anti-Müllerian Hormone (AMH) Levels [Срок оценки: Baseline to 12 weeks]
  • Change in Antral Follicle Count (AFC) [Срок оценки: Baseline to 12 weeks]
  • Change in Reproductive Hormone Levels [Срок оценки: Baseline to 12 weeks]

Критерии участия

Критерии включения

  • Women aged 20-40 years
  • Diagnosed with infertility or planning assisted reproductive treatment
  • Regular menstrual cycles (21-35 days)
  • Willing to participate in a 12-week lifestyle intervention program
  • Able to provide written informed consent

Критерии исключения

  • Known chromosomal abnormalities or genetic disorders affecting fertility
  • History of ovarian surgery or severe ovarian damage
  • Diagnosed endocrine disorders affecting reproduction (e.g., uncontrolled thyroid disease, hyperprolactinemia)
  • Severe systemic diseases (e.g., cardiovascular, hepatic, renal diseases)
  • Current pregnancy or breastfeeding
  • Use of hormonal medications or supplements affecting ovarian function within the past 3 months
  • Participation in another clinical trial within the past 3 months

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07581444 · M20260112

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗