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NCT Number: NCT07581444

Early Prevention and Precision Management of Female Fertility Decline

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.

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Key information

Conditions

Female Fertility Decline Diminished Ovarian Reserve Infertility Prevention Reproductive Health

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Lifestyle Intervention

Behavioral

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.

Routine Clinical Care

Other

Participants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program.

Primary outcomes

  1. Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. Change in Anti-Müllerian Hormone (AMH) Levels

    Time frame: Baseline to 12 weeks

  2. Change in Antral Follicle Count (AFC)

    Time frame: Baseline to 12 weeks

  3. Change in Reproductive Hormone Levels

    Time frame: Baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Development and Evaluation of a Precision Prevention Strategy for Early Female Fertility Decline Based on OvaRePred-Plus: A Multicenter Cluster Randomized Controlled Trial

Acronym: OvaRePred-Plus

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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