NCT07615634

Brief 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. 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026May 2028

First Submitted

Initial submission to the registry

May 6, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

May 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2028

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 6, 2026

Last Update Submit

May 28, 2026

Conditions

Reproductive Issues

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    after 30 minutes of co-culture

  • beta hCG positivity

    up to 24 weeks of IUI

  • Infection or other complications

    up to 24 weeks of IUI

  • Miscarriage

    up to 24 weeks of IUI

  • Multiple pregnancy

    up to 24 weeks of IUI

  • +2 more secondary outcomes

Study Arms (2)

non-PRP group (control group)

SHAM COMPARATOR

non-PRP group (control group): non-PRP in the conventional IUI

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

Other: PRP group (intervention group)

Interventions

non-PRP group (control group)OTHER

non-PRP group (control group): non-PRP in the conventional IUI

non-PRP group (control group)
PRP group (intervention group)OTHER

PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI

PRP group (intervention group)

Eligibility Criteria

Age18 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

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

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 29, 2026

Study Start

May 21, 2026

Primary Completion (Estimated)

November 20, 2027

Study Completion (Estimated)

May 20, 2028

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)