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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-42
SponsorChinese University of Hong Kong

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • non-PRP group (control group)

    Other intervention

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

  • PRP group (intervention group)

    Other intervention

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

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: non-PRP group (control group)Sham comparator 1 intervention
Group B: PRP group (intervention group)Experimental treatment 1 intervention

Trial outcomes

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.

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 outcomes

1

Sperm motility

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

Time frame
after 30 minutes of co-culture
2

beta hCG positivity

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

Time frame
up to 24 weeks of IUI
3

Infection or other complications

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

Time frame
up to 24 weeks of IUI
4

Miscarriage

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

Time frame
up to 24 weeks of IUI

Other outcomes

Sponsors and contacts

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