Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Husband's Sperm

NCT07282327 | Not Yet Recruiting DMC

• 1 other identifier: 2025.450-T
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Reproductive Issues

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  up to 24 weeks of IUI

• Sperm quality

  up to 24 weeks of IUI

Study Arms (2)

Control group

SHAM COMPARATOR

Control group (non-PRP in the conventional IUI)

Other: Sham Comparator: Control group

Intervention group

EXPERIMENTAL

Intervention group (Female PRP co-incubation with husband's sperm in the IUI)

Other: Female PRP co-incubation with husband's sperm in the IUI

Interventions

Female PRP co-incubation with husband's sperm in the IUI OTHER

Intervention group (Female PRP co-incubation with husband's sperm in the IUI)

Intervention group

Sham Comparator: Control group OTHER

Control group (non-PRP in the conventional IUI)

Control group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Obstetrics & Gynaecology The Chinese University of Hong Kong

Hong Kong, China

Location

Study Officials

• Jacqueline Pui Wah Chung

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Pui Wah Chung

CONTACT

85235051537; jacquelinechung@cuhk.edu.hk

Jacqueline Pui Wah Chung

CONTACT

+85235051537; jacquelinechung@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: (i) intervention group: female PRP co-incubation with husband's sperm in the IUI (ii) control group: non-PRP in the conventional IUI.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: December 15, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)