Standardization and Application of Pure Platelet-Rich Pla... | NCT07348354

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

NCT07348354

Sponsor

Chinese University of Hong Kong

Status

Not yet recruiting

Last Update Posted

Jan 22, 2026Actual

Enrollment

248Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Standard culture
PRP culture

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2026Estimated

Primary Completion Date

Jun 18, 2027Estimated

Completion Date

Dec 19, 2027Estimated

First Submitted Date

Dec 2, 2025

First Submission Date that Met QC Criteria

Jan 8, 2026

First Posted Date

Jan 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2026

Last Update Posted Date

Jan 22, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

248Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Standard culture	Other	Only sperm culture	Non-PRP group
PRP culture

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Chung Pui Wah Jacqueline		Hong Kong			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.