Early Prevention and Precision Management of Female Fertility Decline

Starting soon · Not applicable

Conditions studied: Female Fertility Decline, Diminished Ovarian Reserve, Reproductive Health, Infertility Prevention

In brief

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.

Key facts

Study ID

NCT07581444

Run by

Peking University Third Hospital

People needed

384

Starts

2026-06-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-12

Who can join

Age: 20 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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