Early Prevention and Precision Management of Female Fertility Decline (OvaRePred-Plus)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
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.
|
|
Aktiv komparator: 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.
|
Participants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks
Tidsramme: Baseline to 12 weeks
|
Baseline to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Anti-Müllerian Hormone (AMH) Levels
Tidsramme: Baseline to 12 weeks
|
Baseline to 12 weeks
|
|
Change in Antral Follicle Count (AFC)
Tidsramme: Baseline to 12 weeks
|
Baseline to 12 weeks
|
|
Change in Reproductive Hormone Levels
Tidsramme: Baseline to 12 weeks
|
Baseline to 12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- M20260112
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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