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.
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
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)
Parallel
Comprehensive Lifestyle Intervention
BehavioralA 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 monitoring tools to enhance adherence and behavior change.
Routine Clinical Care
Other interventionParticipants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program.
Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks
Change in Anti-Müllerian Hormone (AMH) Levels
Change in Antral Follicle Count (AFC)
Change in Reproductive Hormone Levels
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