Standardization and Application of Pure Platelet-Rich Plasma in Improving Sperm Function

Sponsor
Chinese University of Hong Kong
Study ID
NCT07348354
Status
Not Yet Recruiting

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Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard culture — OTHER
    Only sperm culture
  • PRP culture — OTHER
    PRP 2-5% will be co-culture with sperm

Study Details

Phase 1: Standardize and validate pure platelet-rich plasma (P-PRP) protocol Aims: To validate a standardized double-spin protocol for preparing pure platelet-rich plasma (P-PRP) in an IVF laboratory setting by assessing its platelet yield, purity, and reproducibility. Outcomes Primary outcome Platelet concentration in PRP Absolute platelet count in P-PRP and fold-increase compared to whole blood Secondary outcome Platelet recovery (%): (Platelet count in P-PRP × P-PRP volume) / (Whole blood platelet count × blood volume) × 100 Purity: White blood cell (WBC) concentration in P-PRP Growth factors :e.g.. VEGF, PDGF-AB, TGF-β, IGF-1… concentrations in plasma of PPP and P-PRP preparation Reproducibility Metrics: Coefficient of variation (CV%), intraclass correlation coefficient (ICC), and Bland-Altman limits of agreement for technical and biological duplicates. Phase 2: Examine the effect of pure platelet-rich plasma (P-PRP) on sperm parameters Hypotheses and objectives Hypotheses The investigator hypothesizes that co-culture of semen with pure platelet-rich plasma (P-PRP) enhances sperm quality by increasing motility compared to standard culture medium without P-PRP (control group). Primary outcome \- To compare total sperm motility after 24 hours of co-culture between semen samples co-cultured with P-PRP versus a control group (without P-PRP). Secondary outcome * To compare sperm parameters after other timepoints of co-culture between semen samples co-cultured with P-PRP versus a control group (without P-PRP). * To compare the morphology and DNA Fragmentation Index (DFI) in semen samples after 24-hour co-culture with P-PRP versus control.

Key Dates

First listed
Jan 16, 2026
Start date
Jan 22, 2026
Status verified
Jan 2026
Primary completion
Jun 18, 2027
Completion
Dec 19, 2027

Study Design

Enrollment
248 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Non-PRP group
    Sperm after washing without co-culture
  • Experimental: PRP group
    Sperm after washing with PRP co-culture

Primary Outcome Measure

Phase I: Platelet concentration in PRP [ Time Frame: Baseline ]

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