NCT07615634尚未招募不适用
The Efficacy and Safety of Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Sperm During the Intrauterine Insemination (IUI) Cycles: 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
研究概览
简要总结
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
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 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
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
- •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
研究者
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong
研究点 (1)
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