Early Prevention and Precision Management of Female Fertility Decline (OvaRePred-Plus)

Peking University

Status: Not yet enrolling

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

Treatments: Behavioral: Comprehensive Lifestyle Intervention; Other: Routine Clinical Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07581444

M20260112

Details and patient eligibility

About

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.

Enrollment: 384 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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384 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Comprehensive Lifestyle Intervention

Control Group

Active Comparator group

Description:

Participants receive routine clinical care, including medical history assessment, hormonal testing, ultrasound evaluation, and general health advice without a structured lifestyle intervention program.

Treatment:

Other: Routine Clinical Care