Female Fertility DeclineOvaRePred-PlusNCT07581444
Early Prevention and Precision Management of Female Fertility Decline
A study testing Comprehensive Lifestyle Intervention and Routine Clinical Care in people with Female Fertility Decline and Diminished Ovarian Reserve, run by Peking University Third Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Female Fertility Decline, Diminished Ovarian Reserve, Reproductive Health
- What is being tested?
- Comprehensive Lifestyle Intervention and Routine Clinical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read more
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
- Female Fertility Decline, Diminished Ovarian Reserve, Reproductive Health, Infertility Prevention
- Being tested
- Comprehensive Lifestyle Intervention, Routine Clinical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Lifestyle InterventionBehavioural
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 CareOther
Participants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks
Measured: Baseline to 12 weeks
Secondary outcomes (3)
Change in Anti-Müllerian Hormone (AMH) Levels
Measured: Baseline to 12 weeks
Change in Antral Follicle Count (AFC)
Measured: Baseline to 12 weeks
Change in Reproductive Hormone Levels
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Fertility DeclineStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581444
- Sponsor's protocol ID
- M20260112
- Acronym
- OvaRePred-Plus
- Status last verified
- Apr 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Precision Prevention Strategy for Early Female Fertility Decline Based on OvaRePred-Plus: A Multicenter Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07581444
- Acronym / sponsor ID
- OvaRePred-Plus / M20260112
- Conditions
- Female Fertility Decline, Diminished Ovarian Reserve, Reproductive Health, Infertility Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Comprehensive Lifestyle InterventionParticipants 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. |
| Control Group | Active comparator | Other: Routine Clinical CareParticipants receive routine clinical care, including medical history assessment, hormonal testing, ultrasound evaluation, and general health advice without a structured lifestyle intervention program. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Lifestyle InterventionA 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. | Behavioural | Intervention Group |
| Routine Clinical CareParticipants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program. | Other | Control Group |
Primary outcome
Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks
Time frame: Baseline to 12 weeks
3 secondary outcomes
Change in Anti-Müllerian Hormone (AMH) Levels
Time frame: Baseline to 12 weeks
Change in Antral Follicle Count (AFC)
Time frame: Baseline to 12 weeks
Change in Reproductive Hormone Levels
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Lifestyle Intervention and Routine Clinical Care in people with Female Fertility Decline and Diminished Ovarian Reserve, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.