Diminished Ovarian Reserve, Female Fertility Decline, Infertility Prevention, Reproductive Health
Conditions
Brief 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.
Interventions
BEHAVIORALComprehensive 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.
Participants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
This is a multicenter, cluster randomized controlled trial. Six medical centers are randomized into intervention and control groups (3 centers per group). Participants within each center receive the same allocation. The intervention group receives a 12-week comprehensive health management program, while the control group receives routine clinical care.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks | Baseline to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed