[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638840":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":26,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":26,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":26},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","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\u002Fweek 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.",[13],"Behavioral: Comprehensive Lifestyle Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Participants receive routine clinical care, including medical history assessment, hormonal testing, ultrasound evaluation, and general health advice without a structured lifestyle intervention program.",[19],"Other: Routine Clinical Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","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 monitoring tools to enhance adherence and behavior change.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100638840","early-prevention-and-precision-management-of-female-fertility-decline-100638840",false,"NCT07581444","Early Prevention and Precision Management of Female Fertility Decline","Development and Evaluation of a Precision Prevention Strategy for Early Female Fertility Decline Based on OvaRePred-Plus: A Multicenter Cluster Randomized Controlled Trial","OvaRePred-Plus","Inclusion Criteria:\n\n* Women aged 20-40 years\n* Diagnosed with infertility or planning assisted reproductive treatment\n* Regular menstrual cycles (21-35 days)\n* Willing to participate in a 12-week lifestyle intervention program\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Known chromosomal abnormalities or genetic disorders affecting fertility\n* History of ovarian surgery or severe ovarian damage\n* Diagnosed endocrine disorders affecting reproduction (e.g., uncontrolled thyroid disease, hyperprolactinemia)\n* Severe systemic diseases (e.g., cardiovascular, hepatic, renal diseases)\n* Current pregnancy or breastfeeding\n* Use of hormonal medications or supplements affecting ovarian function within the past 3 months\n* Participation in another clinical trial within the past 3 months","FEMALE","20 Years","40 Years",{"count":45,"type":46},384,"ESTIMATED","INTERVENTIONAL",[49],"NA","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.\n\nThis 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.\n\nParticipants 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.\n\nThe 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.\n\nThis study is expected to provide evidence for a scalable and cost-effective strategy for early prevention and management of female fertility decline.",[52,53,54,55],"Female Fertility Decline","Diminished Ovarian Reserve","Reproductive Health","Infertility Prevention","NOT_YET_RECRUITING","2026-05-06",{"date":59,"type":60},"2026-05-12","ACTUAL",{"date":62,"type":46},"2026-06",{"date":64,"type":46},"2026-12",{"name":5,"class":6}]