Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium - a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Study of the effect of therapy on the onset of pregnancy
研究概览
简要总结
The investigation is devoted to the study of the effect of the introduction of autologous platelet-rich plasma (PRP) on the thickness of the endometrium. It was found that the injection of PRP and endometrial cells resuspended in PRP into the endometrium of patients with thin endometrium leads to an increase in the proliferation of endometrial cells, and as a result, to an increase in its thickness.
详细描述
The study enrolled 115 patients with thin endometrium (<7 mm at implantation window) and infertility. The cohort was divided into groups based on the treatment regimen.
Group 1 (the control, n=30) underwent conservative therapy. Group 2 (n=42) received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 (n=38) received identical injections after conservative therapy. Group 4 (n=5) received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.
Injections of PRP and endometrial cells suspended in autologous PRP into basal layer of endometrium facilitate the reconstitution by enhancing cell proliferation and angiogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years
- •Normal karyotype
- •Normal karyotype of the partner
- •Regular ovulatory and menstrual cycle
- •Endometrium <7 mm thick as measured at implantation window
- •Availability of ≥2 vitrified blastocysts of good quality
- •History of implantation failure and/or embryo transfer (ET) cancellation due to insufficient endometrial thickness
排除标准
- •Pathospermia in partner
- •Use of donor gametes
- •Premature ovarian failure
- •Internal genital anomalies
- •Systemic blood diseases and coagulopathy
- •Hemoglobin <100 g/L
- •Platelets <100×109/L
- •Antiplatelet/anticoagulant therapy recipient status
结局指标
主要结局
Study of the effect of therapy on the onset of pregnancy
时间窗: 9 months
Investigation of the rates of clinical pregnancies and live births in all groups. After therapy, the number of clinical pregnancy and the number of live births were calculated.
Change in endometrial thickness after treatment compared with control.
时间窗: Baseline and 2 month
Ultrasonography measurements of endometrial thickness before and after the therapy and compare the thickness. Endometrial thickness measured in mm.
The Doppler-assisted detection of the uterine spiral arteries
时间窗: 1 month
The number of identified vessels is counted and the percentage of detection frequency is calculated accordingly, adjusted for the McNemar's binomial test. Compare the rates of visualization of the uterine spiral arteries after therapy in all groups of patients.
The content of growth factor in autologous PRP
时间窗: 3 month
Investigation of the content of platelet-derived growth factor-BB (PDGF-BB) and vascular endothelial growth factor (VEGF) in autologous PRP. Relative levels of PDGF-BB and VEGF are normalized to the total protein content.
Phenotyping of cells isolated from endometrial biopsies
时间窗: 3 month
Investigation of cellular composition in endometrial biopsy. The percentage of cells positive for markers of mesenzymal stromal cells, epithelial and endothelial cells, lymphocytes is calculated and the determination of the phenotype of cells in endometrial biopsy.
次要结局
未报告次要终点