Prospective Study on Endometrial Immune Profile Changes After Autologous Intrauterine Platelet Rich Plasma (PRP) Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quantitative immunohistochemical comparison of endometrial T, NK cells and macrophages (%) before and after intrauterine PRP administration
研究概览
简要总结
The success rate after treatment by in-vitro fertilisation (IVF) strongly depends on the endometrial receptivity, which in turn is strictly connected to the endometrial immune profile. IVF outcome is largely dependent upon endometrial immune cell ratios and their relationship with one another.
During the last few years there are several studies and case reports for intrauterine PRP application in patients resulting in a thicker, regenerated endometrium and better immune cell population ratios.
In this project, the investigators aim to analyze the effect of autologous intrauterine PRP administration on the endometrial immune profile, endometrial thickness, selected hormone levels (E2, P4) during the mid-luteal phase and IVF outcomes (biochemical and clinical pregnancy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participating in Assisted Reproduction Treatment
- •Having infertility
- •Having regular menstrual cycles
- •Embryo transfer of euploid embryos
排除标准
- •Uterine pathologies
- •Endometrial Bacterial infections
- •Active endometrial inflammation
- •Polycystic ovary syndrome
- •Cancer diagnostics
- •Positive HIV, HCV or HBV tests
- •Autoimmune diseases
- •Recent immune therapy
研究组 & 干预措施
Intrauterine PRP
干预措施: Platelet rich plasma (PRP) (Biological)
结局指标
主要结局
Quantitative immunohistochemical comparison of endometrial T, NK cells and macrophages (%) before and after intrauterine PRP administration
时间窗: 1 month after PRP administration
Immunohistochemical analysis of paired endometrial biopsies (before and after PRP administration) and comparison of the quantities of T, NK cells and macrophages.
次要结局
- Changes in endometrial thickness (mm) measured by transvaginal ultrasound (TVUS)(1 month after PRP administration)
- Quantitative changes in peripheral blood estradiol (E2, pg/mL) levels before and after PRP administration(1 month after PRP administration)
- Quantitative changes in peripheral blood progesterone (P4, ng/mL) levels before and after PRP administration(1 month after PRP administration)
- Number of patients with successful implantation (positive β-hCG blood test) folllowing embryo transfer after intrauterine PRP administration(Up to 10 weeks after PRP administration)
- Number of patients with clinical pregnancy (ultrasound confirmed gestational sac and/or fetal heartbeat) following embryo transfer after PRP administration(12 weeks after PRP treatment)