Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Endometrial Thickness
研究概览
简要总结
Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to standard therapies, present a significant clinical challenge. The aim of this trial is to assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial lining thickness in patients with thin lining or Asherman's Syndrome.
详细描述
BACKGROUND:
There is a need for new and more effective therapies for patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly for patients resistant to standard therapies
HYPOTHESIS:
Platelet rich plasma stimulates cellular processes involved in endometrial regeneration relevant to management of a thin lining or intrauterine scarring.
PRIMARY AIMS:
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
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Persistent thin lining < 6mm on >1 cycle in previous IVF or FET cycle OR moderate-to-severe Asherman's syndrome
排除标准
- •Age <18 years old or >43 years old,
- •Pregnancy,
- •Diagnosis of cancer,
- •Hb <11 g/dL, platelets <150,000/mm3,
- •Anticoagulation,
- •NSAIDs in the 10 days before procedure
- •Any significant comorbidity or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- •Incision in the uterus: myomectomy; cesarean section
结局指标
主要结局
Endometrial Thickness
时间窗: 3-30 days after treatment
Endometrial thickness will be measured using transvaginal ultrasound per standard protocol
次要结局
- Number of Participants With Ultrasound Confirmed Clinical Pregnancies(at least 7 weeks after treatment)