InfertilityNCT07348354
Standardization and Application of Pure Platelet-Rich Plasma in Improving Sperm Function
A study testing Standard culture and PRP culture in people with Infertility, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Standard culture and PRP culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2026to 19 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female volunteer aged 18-45 years, willing to donate their blood
- Adequate sperm samples (raw sample TMS > 5 x 106)
- BMI <30 kg/m2
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Dr. Chung Pui Wah Jacqueline
Hong Kong
Chung PW Jacqueline, 35053489, jacquelinechung@cuhk.edu.hk
About this study
Phase 1: Standardize and validate pure platelet-rich plasma (P-PRP) protocol
Aims:
Read more
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
- Being tested
- Standard culture, PRP culture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cultureOther
Only sperm culture
PRP cultureOther
PRP 2-5% will be co-culture with sperm
| Study group | Role | What they receive |
|---|---|---|
| Non-PRP group | Experimental | Sperm after washing without co-culture Receives: Other: Standard culture |
| PRP group | Experimental | Sperm after washing with PRP co-culture Receives: Other: PRP culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Platelet concentration in PRP
Absolute platelet count in P-PRP
Measured: 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).
Measured: Up to 24 hours
Secondary outcomes (7)
Phase I: Platelet recovery (%)
Platelet recovery (%)=(Platelet count in P-PRP × P-PRP volume) / (Whole blood platelet count × blood volume) × 100 in PRP
Measured: Baseline
VEGF
Growth factors VEGF concentration
Measured: Up to 8 weeks
TGF-β
Growth factors PDGF-A concentration
Measured: Up to 8 weeks
IGF-1
Growth factors IGF-1concentration
Measured: Up to 8 weeks
Sperm progressive motility
Sperm progressive motility
Measured: Up to 24 hours
Sperm non-progressive motility
Sperm non-progressive motility
Measured: Up to 24 hours
Sperm immotility
Sperm immotility
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start22 Jan 2026 (estimated)
- Primary completion18 Jun 2027 (estimated)
- Study completion19 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348354
- Sponsor's protocol ID
- 2025.681
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization and Application of Pure Platelet-Rich Plasma in Improving Sperm Function
- ClinicalTrials.gov ID
- NCT07348354
- Acronym / sponsor ID
- 2025.681
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Jan 2026 (estimated)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 19 Dec 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-PRP group | Experimental | Other: Standard cultureSperm after washing without co-culture |
| PRP group | Experimental | Other: PRP cultureSperm after washing with PRP co-culture |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female volunteer aged 18-45 years, willing to donate their blood
- Adequate sperm samples (raw sample TMS > 5 x 106)
- BMI <30 kg/m2
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard cultureOnly sperm culture | Other | Non-PRP group |
| PRP culturePRP 2-5% will be co-culture with sperm | Other | PRP group |
Primary outcome
Phase I: Platelet concentration in PRP
Time frame: Baseline
Absolute platelet count in P-PRP
Phase II: total sperm motility
Time frame: 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).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard culture and PRP culture in people with Infertility, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Platelet concentration in PRP (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.