Reproductive Issues
Conditions
Brief summary
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
Interventions
OTHERnon-PRP group (control group)
non-PRP group (control group): non-PRP in the conventional IUI
OTHERPRP group (intervention group)
PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
* non-PRP group (control group): non-PRP in the conventional IUI. * PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI
Eligibility
Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 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
| Measure | Time frame | Description |
|---|---|---|
| Sperm motility | after 30 minutes of co-culture | To evaluate the Sperm motility between the intervention group and control group |
| beta hCG positivity | up to 24 weeks of IUI | To evaluate the rate of beta hCG positivity between the intervention group and control group |
| Infection or other complications | up to 24 weeks of IUI | To evaluate the rate of potential infection in the intervention group and control group |
| Miscarriage | up to 24 weeks of IUI | To determine to the rate miscarriage outcome in the intervention group and control group |
| Multiple pregnancy | up to 24 weeks of IUI | To determine to the rate of multiple pregnancy in the intervention group and control group |
| Ectopic pregnancy | up to 24 weeks of IUI | To determine to the rate of ectopic pregnancy in the intervention group and control group |
| Molar pregnancy | up to 24 weeks of IUI | To determine to the rate of molar pregnancy in the intervention group and control group |
Countries
China
Outcome results
None listed