Infertility
Conditions
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.
Interventions
OTHERStandard culture
Only sperm culture
OTHERPRP culture
PRP 2-5% will be co-culture with sperm
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Platelet concentration in PRP | Baseline | Absolute platelet count in P-PRP |
| Phase II: total sperm motility | Up to 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Platelet recovery (%) | Baseline | Platelet recovery (%)=(Platelet count in P-PRP × P-PRP volume) / (Whole blood platelet count × blood volume) × 100 in PRP |
| VEGF | Up to 8 weeks | Growth factors VEGF concentration |
| TGF-β | Up to 8 weeks | Growth factors PDGF-A concentration |
| IGF-1 | Up to 8 weeks | Growth factors IGF-1concentration |
| Sperm progressive motility | Up to 24 hours | Sperm progressive motility |
| Sperm non-progressive motility | Up to 24 hours | Sperm non-progressive motility |
| Sperm immotility | Up to 24 hours | Sperm immotility |
Countries
China
Outcome results
None listed