The Efficacy and Safety of Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Husband's Sperm in the Intrauterine Insemination (IUI) to Improve Clinical Pregnancy Rate: A Prospective, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Rate of clinical pregnancy
研究概览
简要总结
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
详细描述
Outcome measures
Primary outcome:
To measure the rate of clinical pregnancy outcome in subjects undergoing IUI with PRP co-incubation with husband's sperm group than non-PRP group. Clinical pregnancy rate as determined by a positive serum beta-hCG test result at 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:
- To evaluate the rate of potential infection or other complications such as ectopic pregnancy and molar pregnancy in the intervention group and control group
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
- •Haemoglobin < 11g/dL, platelet count < 150000 mm3
- •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
结局指标
主要结局
Rate of clinical pregnancy
时间窗: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Rate of clinical pregnancy outcome in subjects undergoing IUI with PRP co-incubation with husband's sperm group than non-PRP group.
次要结局
- Rate of potential infection or other complications(up to 24 weeks of IUI)
- Sperm quality(up to 24 weeks of IUI)
研究者
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong