Clinical Trial

Early Prevention and Precision Management of Female Fertility Decline

Study acronym: OvaRePred-Plus
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07581444
Lead Sponsor Peking University Third Hospital
Conditions Female Fertility Decline, Diminished Ovarian Reserve, Reproductive Health, Infertility Prevention
Enrollment 384 participants
Start Date 2026-06
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-12