Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Endometrial Thickness during frozen embryo transfer
研究概览
简要总结
To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.
详细描述
Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness
- •Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.
排除标准
- •Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.
- •Most recent unsuccessful embryo transfer prior to January 1,
- •Mullerian anomalies, excluding arcuate uterus
- •Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery
- •Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
- •Failure of patient to agree to enrollment in study with written consent.
- •Concurrent pregnancy
- •Anticoagulation use for which plasma infusion is contraindicated
- •History of thrombosis
- •Thrombophilia either inherited or acquired
- •Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment.
- •Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia
- •Recurrent/persistent endometrial fluid in prior cycles
研究组 & 干预措施
Control Group
an intrauterine infusion of normal saline will be administered to this group
干预措施: Normal saline Intrauterine infusion (Other)
Intervention Group
an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group
干预措施: Platelet Rich Plasma Intrauterine infusion (Other)
结局指标
主要结局
Endometrial Thickness during frozen embryo transfer
时间窗: during the proliferative phase of the frozen embryo transfer cycle
peak endometrial thickness prior to initiation of progesterone
次要结局
- Sustained implantation rate(approximately 9 weeks gestational age)