Reproductive IssuesNCT07282327
Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Husband's Sperm
A study testing Female PRP co-incubation with husband's sperm in the IUI in people with Reproductive Issues, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Hypotheses: We hypothesize that infertility patients undergoing IUI who receive female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm would have higher clinical pregnancy rate. Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- Reproductive Issues
- What is being tested?
- Female PRP co-incubation with husband's sperm in the IUI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 31 Aug 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 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing IUI cycles
- Infertility patients aged >18 years old and < 42 years old
- BMI <30 kg/m2
- No sexually transmitted diseases, AIDS, syphilis and other infectious disease
Who cannot join
- Concurrent administration of other agents such as prednisolone, intravenous immunoglobulin, or G-CSF
- Administration of anticoagulants or NSAIDs at least 7 days before PRP infuse
- Drug addiction
- Urinary tract infection
- Underlying uncontrolled diabetes or hypertension, chromosomal or uterine abnormalities, genetic, hematologic, immunological, or endocrine disorders
- Chronic disease, systemic disease or cancers
Show all 11Show fewer
- Blood diseases (sepsis, thrombocytopenia)
- Haemoglobin < 11g/dL, platelet count < 150000 mm3
- Poor sperm samples (raw sample TMS <5 x 106)
- Smoking and drinking alcoholic beverages on the day of IUI
- Fever on the day of IUI
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
Department of Obstetrics & Gynaecology The Chinese University of Hong Kong
Hong Kong
Jacqueline Pui Wah Chung, +852 3505 1537, jacquelinechung@cuhk.edu.hk
About this study
Official title: The Efficacy and Safety of Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Husband's Sperm in the Intrauterine Insemination (IUI) to Improve Clinical Pregnancy Rate: A Prospective, Randomized Controlled Trial.
Hypotheses:
We hypothesize that infertility patients undergoing IUI who receive female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm would have higher clinical pregnancy rate.
Read more
Aims:
- To determine if the use of female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm in the IUI will show higher clinical pregnancy rate (CPR). Clinical pregnancy rate as determined by a positive serum beta-hCG test result and at least one gestational sac at 6 weeks gestation
- To assess the safety of female PRP co-incubation with husband's sperm in the IUI.
Primary outcome:
To compare the incidence of clinical pregnancy outcome in those infertility patients undergoing IUI with female PRP co-incubation with husband's sperm group and non-PRP group.
Secondary outcomes:
- To evaluate the safeness between the female PRP co-incubation with husband's sperm in the IUI group and non-PRP group, including potential infection rate or other complications such as ectopic pregnancy and molar pregnancy
- To evaluate the sperm quality between the intervention group and control group
Data analysis: Data analysis will be performed using Statistical Packages of Social Sciences for Windows
Expected results: The investigators expect that a 50% pregnancy rate increase after the application of female PRP co-incubation with husband's sperm in the IUI
Read the detailed description
Outcome measures
Primary outcome:
To measure the rate of clinical pregnancy outcome in subjects undergoing IUI with PRP co-incubation with husband's sperm group than non-PRP group. Clinical pregnancy rate as determined by a positive serum beta-hCG test result at 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Secondary outcomes:
- To evaluate the rate of potential infection or other complications such as ectopic pregnancy and molar pregnancy in the intervention group and control group
- Assessment of sperm quality Sperm quality will be assessed before raw semen, post isolated processed semen and after female PRP co-incubation with the processed semen
Sample size IUI's average clinical pregnancy rate is 10.1% in the past five years at Assisted Reproductive Technology Unit of the department of Obstetrics and Gynecological in the Prince of Wales Hospital, we assume a 50% pregnancy rate increase after the application of female PRP co-incubation with husband's sperm in the IUI, the pregnancy rate is expected to be 15.15% in the sample size estimation. With power calculations (G*Power3.1.9.7; t tests-Means: difference of two independent means), 64 couples (128 patients) in each arm would provide a two-sided 80% power with an alpha of 0.05. We aim to recruit a total of 144 couples (288 patients), that is 72 couples (144 patients) in each arm, to account for a 10% dropout rate.
Subjects undergoing IUI will be included in the study if they fulfilled the inclusion criteria. The consented subjects will be randomized into two groups via simple random sampling. The subjects' names will be drawn randomly from a pool in which each had an equal probability of being chosen.
- Intervention group (Female PRP co-incubation with husband's sperm in the IUI)
- Control group (non-PRP in the conventional IUI)
Data processing and analysis The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handles subject data. The computer data will be encrypted as required to maximize security. All paper documents will be locked in filing cabinets, and only authorized personnel could access this information. Data will be stored for up to 10 years.
Statistical analysis will be performed using the SPSS (SPSS Inc. Chicago, IL, USA). Data will be presented by percentage, mean and standard deviation, and median where appropriate. Chi-square test, Fisher's exact test, student-t test will be used for data analysis where appropriate. A two-tailed probability value of p< 0.05 will be considered statistically significant.
- Conditions
- Reproductive Issues
- Being tested
- Female PRP co-incubation with husband's sperm in the IUI, Sham Comparator: Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Female PRP co-incubation with husband's sperm in the IUIOther
Intervention group (Female PRP co-incubation with husband's sperm in the IUI)
Sham Comparator: Control groupOther
Control group (non-PRP in the conventional IUI)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Control group (non-PRP in the conventional IUI) Receives: Other: Sham Comparator: Control group |
| Intervention group | Experimental | Intervention group (Female PRP co-incubation with husband's sperm in the IUI) Receives: Other: Female PRP co-incubation with husband's sperm in the IUI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical pregnancy
Rate of clinical pregnancy outcome in subjects undergoing IUI with PRP co-incubation with husband's sperm group than non-PRP group.
Measured: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Secondary outcomes (2)
Rate of potential infection or other complications
To evaluate the rate of potential infection or other complications such as ectopic pregnancy and molar pregnancy in the intervention group and control group
Measured: up to 24 weeks of IUI
Sperm quality
Assessment of sperm quality Sperm quality will be assessed before raw semen, post isolated processed semen and after female PRP co-incubation with the processed semen
Measured: up to 24 weeks of IUI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive IssuesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- (i) intervention group: female PRP co-incubation with husband's sperm in the IUI (ii) control group: non-PRP in the conventional IUI.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 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
- Investigators
- Jacqueline Pui Wah Chung, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282327
- Sponsor's protocol ID
- 2025.450-T
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Husband's Sperm in the Intrauterine Insemination (IUI) to Improve Clinical Pregnancy Rate: A Prospective, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07282327
- Acronym / sponsor ID
- 2025.450-T
- Conditions
- Reproductive Issues
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Dec 2025 (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.
Hypotheses:
We hypothesize that infertility patients undergoing IUI who receive female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm would have higher clinical pregnancy rate.
Aims:
- To determine if the use of female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm in the IUI will show higher clinical pregnancy rate (CPR). Clinical pregnancy rate as determined by a positive serum beta-hCG test result and at least one gestational sac at 6 weeks gestation
- To assess the safety of female PRP co-incubation with husband's sperm in the IUI.
Primary outcome:
To compare the incidence of clinical pregnancy outcome in those infertility patients undergoing IUI with female PRP co-incubation with husband's sperm group and non-PRP group.
Secondary outcomes:
- To evaluate the safeness between the female PRP co-incubation with husband's sperm in the IUI group and non-PRP group, including potential infection rate or other complications such as ectopic pregnancy and molar pregnancy
- To evaluate the sperm quality between the intervention group and control group
Data analysis: Data analysis will be performed using Statistical Packages of Social Sciences for Windows
Expected results: The investigators expect that a 50% pregnancy rate increase after the application of female PRP co-incubation with husband's sperm in the IUI
Detailed description
Outcome measures
Primary outcome:
To measure the rate of clinical pregnancy outcome in subjects undergoing IUI with PRP co-incubation with husband's sperm group than non-PRP group. Clinical pregnancy rate as determined by a positive serum beta-hCG test result at 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Secondary outcomes:
- To evaluate the rate of potential infection or other complications such as ectopic pregnancy and molar pregnancy in the intervention group and control group
- Assessment of sperm quality Sperm quality will be assessed before raw semen, post isolated processed semen and after female PRP co-incubation with the processed semen
Sample size IUI's average clinical pregnancy rate is 10.1% in the past five years at Assisted Reproductive Technology Unit of the department of Obstetrics and Gynecological in the Prince of Wales Hospital, we assume a 50% pregnancy rate increase after the application of female PRP co-incubation with husband's sperm in the IUI, the pregnancy rate is expected to be 15.15% in the sample size estimation. With power calculations (G*Power3.1.9.7; t tests-Means: difference of two independent means), 64 couples (128 patients) in each arm would provide a two-sided 80% power with an alpha of 0.05. We aim to recruit a total of 144 couples (288 patients), that is 72 couples (144 patients) in each arm, to account for a 10% dropout rate.
Subjects undergoing IUI will be included in the study if they fulfilled the inclusion criteria. The consented subjects will be randomized into two groups via simple random sampling. The subjects' names will be drawn randomly from a pool in which each had an equal probability of being chosen.
- Intervention group (Female PRP co-incubation with husband's sperm in the IUI)
- Control group (non-PRP in the conventional IUI)
Data processing and analysis The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handles subject data. The computer data will be encrypted as required to maximize security. All paper documents will be locked in filing cabinets, and only authorized personnel could access this information. Data will be stored for up to 10 years.
Statistical analysis will be performed using the SPSS (SPSS Inc. Chicago, IL, USA). Data will be presented by percentage, mean and standard deviation, and median where appropriate. Chi-square test, Fisher's exact test, student-t test will be used for data analysis where appropriate. A two-tailed probability value of p< 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- (i) intervention group: female PRP co-incubation with husband's sperm in the IUI (ii) control group: non-PRP in the conventional IUI.
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Sham Comparator: Control groupControl group (non-PRP in the conventional IUI) |
| Intervention group | Experimental | Other: Female PRP co-incubation with husband's sperm in the IUIIntervention group (Female PRP co-incubation with husband's sperm in the IUI) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients undergoing IUI cycles
- Infertility patients aged >18 years old and < 42 years old
- BMI <30 kg/m2
- No sexually transmitted diseases, AIDS, syphilis and other infectious disease
Key exclusion criteria (11 listed)
- Concurrent administration of other agents such as prednisolone, intravenous immunoglobulin, or G-CSF
- Administration of anticoagulants or NSAIDs at least 7 days before PRP infuse
- Drug addiction
- Urinary tract infection
- Underlying uncontrolled diabetes or hypertension, chromosomal or uterine abnormalities, genetic, hematologic, immunological, or endocrine disorders
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 |
|---|---|---|
| Female PRP co-incubation with husband's sperm in the IUIIntervention group (Female PRP co-incubation with husband's sperm in the IUI) | Other | Intervention group |
| Sham Comparator: Control groupControl group (non-PRP in the conventional IUI) | Other | Control group |
Primary outcome
Rate of clinical pregnancy
Time frame: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Rate of clinical pregnancy outcome in subjects undergoing IUI with PRP co-incubation with husband's sperm group than non-PRP group.
2 secondary outcomes
Rate of potential infection or other complications
Time frame: up to 24 weeks of IUI
Sperm quality
Time frame: up to 24 weeks of IUI
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 15 Dec 2025.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Jacqueline Pui Wah Chung principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Female PRP co-incubation with husband's sperm in the IUI in people with Reproductive Issues, 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 4 inclusion and 11 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 15 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Contact Jacqueline Pui Wah Chung (85235051537, jacquelinechung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical pregnancy (time frame: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.). 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 15 Dec 2025.