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Not yet recruiting NCT07615634

The Efficacy and Safety of Female PRP Co-incubation With Sperm During (IUI) Cycles

No phase Interventional Reproductive Issues

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: non-PRP group (control group), PRP group (intervention group).
Who it may be relevant to
Registry conditions: Reproductive Issues. Basic parameters: 18 years — 42 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • Other non-PRP group (control group)
    non-PRP group (control group): non-PRP in the conventional IUI
  • Other PRP group (intervention group)
    PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07615634 · 2026.182

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗