Reproductive IssuesNCT07615634
The Efficacy and Safety of Female PRP Co-incubation With Sperm During (IUI) Cycles
A study testing PRP group (intervention group) in people with Reproductive Issues, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The investigators 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?
- PRP group (intervention group)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2026to 20 May 2028
- 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 who were eligible for IUI cycles in Assissted Reproduction Technolog unit, Prince of Wales Hospital
- Female patients aged >18 years old and < 42 years old
- BMI < 30 kg/m2
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
- Untreated 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)
- 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
- Redduse or incomplete in obtaining informed consent
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
The Chinese University of Hong Kong
Hong Kong
Chung PW Jacqueline, 35051537, jacquelinechung@cuhk.edu.hk
About this study
Official title: The Efficacy and Safety of Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Sperm During the Intrauterine Insemination (IUI) Cycles: A Prospective, Randomized Controlled Trial
The investigators 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.
Primary outcome:
Read more
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 post-culture sperm parameters between the intervention group and control group
- To evaluate the IUI parameter between the intervention group and control group
- 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 pregnancy outcomes such as miscarriage, multiple pregnancy, ectopic pregnancy and molar pregnancy
- Conditions
- Reproductive Issues
- Being tested
- non-PRP group (control group), PRP group (intervention group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-PRP group (control group)Other
non-PRP group (control group): non-PRP in the conventional IUI
PRP group (intervention group)Other
PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI
| Study group | Role | What they receive |
|---|---|---|
| non-PRP group (control group) | Sham comparator | non-PRP group (control group): non-PRP in the conventional IUI Receives: Other: non-PRP group (control group) |
| PRP group (intervention group) | Experimental | PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI Receives: Other: PRP group (intervention group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
To determine the 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 (7)
Sperm motility
To evaluate the Sperm motility between the intervention group and control group
Measured: after 30 minutes of co-culture
beta hCG positivity
To evaluate the rate of beta hCG positivity between the intervention group and control group
Measured: up to 24 weeks of IUI
Infection or other complications
To evaluate the rate of potential infection in the intervention group and control group
Measured: up to 24 weeks of IUI
Miscarriage
To determine to the rate miscarriage outcome in the intervention group and control group
Measured: up to 24 weeks of IUI
Multiple pregnancy
To determine to the rate of multiple pregnancy in the intervention group and control group
Measured: up to 24 weeks of IUI
Ectopic pregnancy
To determine to the rate of ectopic pregnancy in the intervention group and control group
Measured: up to 24 weeks of IUI
Molar pregnancy
To determine to the rate of molar pregnancy in the intervention group and control group
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 posted29 May 2026
- Study start21 May 2026 (estimated)
- Primary completion20 Nov 2027 (estimated)
- Study completion20 May 2028 (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
- * non-PRP group (control group): non-PRP in the conventional IUI. * PRP group (intervention group): female PRP co-incubation with husband's sperm in the 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615634
- Sponsor's protocol ID
- 2026.182
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 29 May 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 29 May 2026. 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 Sperm During the Intrauterine Insemination (IUI) Cycles: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07615634
- Acronym / sponsor ID
- 2026.182
- 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
- 21 May 2026 (estimated)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 20 May 2028 (estimated)
- First posted
- 29 May 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.
The investigators 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.
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 post-culture sperm parameters between the intervention group and control group
- To evaluate the IUI parameter between the intervention group and control group
- 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 pregnancy outcomes such as miscarriage, multiple pregnancy, ectopic pregnancy and molar pregnancy
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
- * non-PRP group (control group): non-PRP in the conventional IUI. * PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI
| Arm | Type | Receives |
|---|---|---|
| non-PRP group (control group) | Sham comparator | Other: non-PRP group (control group)non-PRP group (control group): non-PRP in the conventional IUI |
| PRP group (intervention group) | Experimental | Other: PRP group (intervention group)PRP group (intervention 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 (3 listed)
- Patients who were eligible for IUI cycles in Assissted Reproduction Technolog unit, Prince of Wales Hospital
- Female patients aged >18 years old and < 42 years old
- BMI < 30 kg/m2
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
- Untreated 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 |
|---|---|---|
| non-PRP group (control group)non-PRP group (control group): non-PRP in the conventional IUI | Other | non-PRP group (control group) |
| PRP group (intervention group)PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI | Other | PRP group (intervention group) |
Primary outcome
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
To determine the rate of clinical pregnancy outcome in subjects undergoing IUI with PRP co-incubation with husband's sperm group than non-PRP group.
7 secondary outcomes
Sperm motility
Time frame: after 30 minutes of co-culture
beta hCG positivity
Time frame: up to 24 weeks of IUI
Infection or other complications
Time frame: up to 24 weeks of IUI
Miscarriage
Time frame: up to 24 weeks of IUI
Multiple pregnancy
Time frame: up to 24 weeks of IUI
Ectopic pregnancy
Time frame: up to 24 weeks of IUI
Molar pregnancy
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 29 May 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 PRP group (intervention group) 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 3 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 29 May 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. 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?
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?
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 29 May 2026.