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Not yet recruiting NCT07348354

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

No phase Interventional Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard culture, PRP culture.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Phase I: Platelet concentration in PRP [Time frame: Baseline]
  • Phase II: total sperm motility [Time frame: Up to 24 hours]
Secondary outcome measures (7)
  • Phase I: Platelet recovery (%) [Time frame: Baseline]
  • VEGF [Time frame: Up to 8 weeks]
  • TGF-β [Time frame: Up to 8 weeks]
  • IGF-1 [Time frame: Up to 8 weeks]
  • Sperm progressive motility [Time frame: Up to 24 hours]
  • Sperm non-progressive motility [Time frame: Up to 24 hours]
  • Sperm immotility [Time frame: Up to 24 hours]

Eligibility criteria

Inclusion criteria

  • Female volunteer aged 18-45 years, willing to donate their blood
  • Adequate sperm samples (raw sample TMS > 5 x 106)
  • BMI <30 kg/m2

Exclusion criteria

  • Concurrent administration of other agents such as prednisolone, intravenous immunoglobulin, or G-CSF
  • Drug addiction
  • Underlying uncontrolled genital infections, diabetes or hypertension, chromosomal or uterine abnormalities, genetic, hematologic, immunological, or endocrine disorders
  • Chronic disease, systemic disease, or cancers
  • Blood diseases (sepsis, thrombocytopenia)
  • Do not agree to donate blood
  • Use of supplements containing antioxidants within the past 3 months
  • Administration of anticoagulants or NSAIDs at least 7 days before P-PRP infuse
  • Haemoglobin < 11g/dL, platelet count < 150000 mm3

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Dr. Chung Pui Wah Jacqueline — Hong Kong

Identifiers

NCT: NCT07348354 · 2025.681

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗