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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Female PRP co-incubation with husband's sperm in the IUI
Other interventionIntervention group (Female PRP co-incubation with husband's sperm in the IUI)
Sham Comparator: Control group
Other interventionControl group (non-PRP in the conventional IUI)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
Sponsors and contacts
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