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NCT Number: NCT07615634

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

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

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Key information

Conditions

Reproductive Issues

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sperm motility

    Time frame: after 30 minutes of co-culture

    To evaluate the Sperm motility between the intervention group and control group

  2. beta hCG positivity

    Time frame: up to 24 weeks of IUI

    To evaluate the rate of beta hCG positivity between the intervention group and control group

  3. Infection or other complications

    Time frame: up to 24 weeks of IUI

    To evaluate the rate of potential infection in the intervention group and control group

  4. Miscarriage

    Time frame: up to 24 weeks of IUI

    To determine to the rate miscarriage outcome in the intervention group and control group

  5. Multiple pregnancy

    Time frame: up to 24 weeks of IUI

    To determine to the rate of multiple pregnancy in the intervention group and control group

  6. Ectopic pregnancy

    Time frame: up to 24 weeks of IUI

    To determine to the rate of ectopic pregnancy in the intervention group and control group

  7. Molar pregnancy

    Time frame: up to 24 weeks of IUI

    To determine to the rate of molar pregnancy in the intervention group and control group

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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