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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Other: Standard culture; Other: PRP culture

• Study Type: Interventional
• Enrollment (Estimated): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Dr. Chung Pui Wah Jacqueline
    • Contact: Chung PW Jacqueline; Phone Number: 35053489; Email: jacquelinechung@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-PRP group; Sperm after washing without co-culture	Other: Standard culture; Only sperm culture
Experimental: PRP group; Sperm after washing with PRP co-culture	Other: PRP culture; PRP 2-5% will be co-culture with sperm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I: Platelet concentration in PRP	Absolute platelet count in P-PRP	Baseline
Phase II: total sperm motility	total sperm motility after 24 hours of co-culture between semen samples co-cultured with P-PRP versus a control group (without P-PRP).	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I: Platelet recovery (%)	Platelet recovery (%)=(Platelet count in P-PRP × P-PRP volume) / (Whole blood platelet count × blood volume) × 100 in PRP	Baseline
VEGF	Growth factors VEGF concentration	Up to 8 weeks
TGF-β	Growth factors PDGF-A concentration	Up to 8 weeks
IGF-1	Growth factors IGF-1concentration	Up to 8 weeks
Sperm progressive motility	Sperm progressive motility	Up to 24 hours
Sperm non-progressive motility	Sperm non-progressive motility	Up to 24 hours
Sperm immotility	Sperm immotility	Up to 24 hours

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 22, 2026
• Primary Completion (Estimated): June 18, 2027
• Study Completion (Estimated): December 19, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 2025.681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No