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

May 28, 2026 updated by: Chung Pui Wah Jacqueline, Chinese University of Hong Kong

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:

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: non-PRP group (control group)
non-PRP group (control group): non-PRP in the conventional IUI
Other: non-PRP group (control group)
non-PRP group (control group): non-PRP in the conventional IUI
Experimental: PRP group (intervention group)
PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI
Other: PRP group (intervention group)
PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Outcome Measure
Measure Description
Time Frame
Sperm motility
Time Frame: after 30 minutes of co-culture
To evaluate the Sperm motility between the intervention group and control group
after 30 minutes of co-culture
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
up to 24 weeks of IUI
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
up to 24 weeks of IUI
Miscarriage
Time Frame: up to 24 weeks of IUI
To determine to the rate miscarriage outcome in the intervention group and control group
up to 24 weeks of IUI
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
up to 24 weeks of IUI
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
up to 24 weeks of IUI
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
up to 24 weeks of IUI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 21, 2026

Primary Completion (Estimated)

November 20, 2027

Study Completion (Estimated)

May 20, 2028

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026.182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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