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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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.
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Comparatore attivo: 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.
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Participants receive standard clinical management, including medical history assessment, hormonal testing, ultrasound evaluation, and general health education, without a structured lifestyle intervention program.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change in Ovarian Reserve Score (OvaRePred) After 12 Weeks
Lasso di tempo: Baseline to 12 weeks
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Baseline to 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change in Anti-Müllerian Hormone (AMH) Levels
Lasso di tempo: Baseline to 12 weeks
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Baseline to 12 weeks
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Change in Antral Follicle Count (AFC)
Lasso di tempo: Baseline to 12 weeks
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Baseline to 12 weeks
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Change in Reproductive Hormone Levels
Lasso di tempo: Baseline to 12 weeks
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Baseline to 12 weeks
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- M20260112
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