Early Prevention and Precision Management of Female Fertility Decline

NCT07581444 | Not Yet Recruiting

• 1 other identifier: M20260112
• Study Type: interventional
• Target: 384
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reproductive Health; Female Fertility Decline; Diminished Ovarian Reserve; Infertility Prevention

Outcome Measures

Primary Outcomes (1)

• Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks

  Baseline to 12 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

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/week 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.

Behavioral: Comprehensive Lifestyle Intervention

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.

Other: Routine Clinical Care

Interventions

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.

Control Group

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.

Intervention Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04