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

May 6, 2026 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

384

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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.
Active Comparator: Control Group
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
Participants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Anti-Müllerian Hormone (AMH) Levels
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks
Change in Antral Follicle Count (AFC)
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks
Change in Reproductive Hormone Levels
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • M20260112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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