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

NCT07348354 | Not Yet Recruiting DMC

• 1 other identifier: 2025.681
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Phase I: Platelet recovery (%)

  Baseline

• VEGF

  Up to 8 weeks

• TGF-β

  Up to 8 weeks

• IGF-1

  Up to 8 weeks

• Sperm progressive motility

  Up to 24 hours

Study Arms (2)

Non-PRP group

EXPERIMENTAL

Sperm after washing without co-culture

Other: Standard culture

PRP group

EXPERIMENTAL

Sperm after washing with PRP co-culture

Other: PRP culture

Interventions

PRP culture OTHER

PRP 2-5% will be co-culture with sperm

PRP group

Standard culture OTHER

Only sperm culture

Non-PRP group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Dr. Chung Pui Wah Jacqueline

Hong Kong, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study will validate the standardized double-spin P-PRP protocol and evaluate its effect on sperm motility and DNA fragmentation after semen co-culture. It aims to enhance sperm quality while ensuring reproducibility and accessibility in clinical practice.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 16, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): June 18, 2027
• Study Completion (Estimated): December 19, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)