Development and Evaluation of a Precision Prevention Strategy for Early Female Fertility Decline Based on OvaRePred-Plus: A Multicenter Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 384
- 主要终点
- Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the behavioral intervention, participants and care providers cannot be blinded. However, outcome assessors responsible for laboratory measurements (e.g., AMH) and data analysis will be blinded to group allocation.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group
Participants receive a 12-week comprehensive lifestyle intervention program, including dietary optimization, nutritional supplementation (vitamin C, vitamin D, and folic acid), structured physical activity (≥150 minutes/week of moderate-intensity exercise), and sleep improvement (7-8 hours per night). The program is supported by biweekly health education sessions and digital monitoring tools.
干预措施: Comprehensive Lifestyle Intervention (Behavioral)
Control Group
Participants receive routine clinical care, including medical history assessment, hormonal testing, ultrasound evaluation, and general health advice without a structured lifestyle intervention program.
干预措施: Routine Clinical Care (Other)
结局指标
主要结局
Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks
时间窗: Baseline to 12 weeks
次要结局
- Change in Anti-Müllerian Hormone (AMH) Levels(Baseline to 12 weeks)
- Change in Antral Follicle Count (AFC)(Baseline to 12 weeks)
- Change in Reproductive Hormone Levels(Baseline to 12 weeks)