Immunological Mechanisms of Rejection in Uterine Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- presence of new markers associated with transplant rejection
研究概览
简要总结
The objective of this study is to understand the mechanisms of rejection in uterine transplantation and to search for non-invasive markers of rejection. The biological samples necessary for our research have been or will be collected during procedures (biopsies, smears, vaginal swab, blood tests) carried out as part of the scheduled follow-up of patients. These will be samples whose collection is minimally or not invasive
详细描述
In the context of uterine transplantation, non-invasive rejection markers will be sought by different approaches, including transcriptomics on a prospective cohort of patients with different types of samples: blood, smear and biopsy. A microbiota study will also be carried out. 3 groups will be studied: 1 group of 10 patients benefiting or having benefited from a uterine transplant, 1 second group made up of their 10 donors, 1 group of 10 control women
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patient going to or having received a uterine transplant OR Patient going to or having donated a uterus for a recipient included in the study OR Premenopausal woman to undergo gynecological surgery under general anesthesia: for 4 of them it was a hysterectomy and they must be under 45 years old, the other 6 must be under 38 years old.
- •Exclusion Criteria (For witness):
- •Pregnancy in progress
- •Current infection
- •Cervical dysplasia
- •History of transplant or transfusion
- •Cancer or history of cancer
- •Menopause
- •Patient aged 38 or over for the 6 controls without hysterectomy, patient aged 45 or over for the 4 patients with hysterectomy.
- •Endometriosis
排除标准
- 未提供
结局指标
主要结局
presence of new markers associated with transplant rejection
时间窗: 8 years
次要结局
- incidence of pregnancy on transplant immunology(8 years)
- microbiota in uterine transplant(8 years)