Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Husband's Sperm

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

About this trial

Hypotheses:

We 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.

Aims:

* To determine if the use of female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm in the IUI will show higher clinical pregnancy rate (CPR). Clinical pregnancy rate as determined by a positive serum beta-hCG test result and at least one gestational sac at 6 weeks gestation * To assess the safety of female PRP co-incubation with husband's sperm in the IUI.

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 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 complications such as ectopic pregnancy and molar pregnancy * To evaluate the sperm quality between the intervention group and control group

Data analysis: Data analysis will be performed using Statistical Packages of Social Sciences for Windows

Expected results: The investigators expect that a 50% pregnancy rate increase after the application of female PRP co-incubation with husband's sperm in the IUI

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing IUI cycles

Infertility patients aged >18 years old and < 42 years old

BMI <30 kg/m2

No sexually transmitted diseases, AIDS, syphilis and other infectious disease

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

Urinary tract infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Female PRP co-incubation with husband's sperm in the IUI

    Other intervention

    Intervention group (Female PRP co-incubation with husband's sperm in the IUI)

  • Sham Comparator: Control group

    Other intervention

    Control group (non-PRP in the conventional IUI)

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: Control groupSham comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of clinical pregnancy

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

Rate of potential infection or other complications

To evaluate the rate of potential infection or other complications such as ectopic pregnancy and molar pregnancy in the intervention group and control group

Time frame
up to 24 weeks of IUI
2

Sperm quality

Assessment of sperm quality Sperm quality will be assessed before raw semen, post isolated processed semen and after female PRP co-incubation with the processed semen

Time frame
up to 24 weeks of IUI

Other outcomes

Sponsors and contacts

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