Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Inflammatory cell population
研究概览
简要总结
A prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section. Eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche. After fixation of the transcervical catheter, we will flush 2 ml sterile NaCl 0.9% into the uterine cavity and aspirate the fluid. After collecting all samples, the samples will be snap frozen and stored at -80o C, until they undergo an immunological analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients suffering from infertility and assigned for a hydrosonography exam for assessment of the integrity of the uterus and fallopian tubes.
排除标准
- •Patients with hydrosalpinx/pyosalpinx/sactosalpinx
- •Patients who went through surgical correction of a niche
- •Hormonal treatment- estrogens or progestins.
- •Immunosuppressive/immunomodulating medication
研究组 & 干预措施
Intact uterus
Patients with intact uterus
干预措施: Uterine lavage (Diagnostic Test)
Scarred uterus
Patients with scarred uterus
干预措施: Uterine lavage (Diagnostic Test)
结局指标
主要结局
Inflammatory cell population
时间窗: Through study completion, an average of 1 year
The wash samples are processed, supernatant discarded and RBCs removed. Cells are then washed with FACS buffer ,subjected to antibody staining and examined by flow cytometry. Antibodies include: CD45,UV,CD3,CD19,CD66B,CD88, CD89, CD14,CD16,CD314,HLA-DR in order to identify monocytes, dendritic cells, T cells, B cells, NK and Neutrophil populations
次要结局
未报告次要终点
研究者
Chana Adler
Principal Investigator, IVF clinic physician
Hadassah Medical Organization