Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Improvement rate of NK cells
研究概览
简要总结
The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.
详细描述
Menstrual blood analysis will be performed on patients with infertility or a history of adverse pregnancy outcomes who have fertility needs. Those with abnormal uterine NK cells function will be screened and given informed consent forms pre-treatment. Collecting peripheral blood from the patients, isolating and inducing in vitro culture to obtain autologous decidual like NK cells which will be perfused into their uterine. Perform continuous menstrual blood analysis within 6 months after the first treatment to assess the improvement of uterine NK cell function. If the function of uterine NK cells improves, enter the stage of attempting pregnancy and follow up pregnancy outcomes; If the function of uterine NK cells does not improve, then autologous decidual like NK cells uterine cavity perfusion therapy will be performed again. NK cells intrauterine infusion will be treated up to 2 times.
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
- 22 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •abnormal uterine NK cell function;
- •have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
- •have clear fertility desires;
- •normal ovarian function or with frozen embryos;
- •edometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase >= 7mm;
- •18kg/m^2 < Body mass index < 30kg/m^2;
排除标准
- •using progesterone receptor modulator;
- •chromosomal karyotype abnormalities in one spouse;
- •severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
- •uncontrolled autoimmune diseases;
- •abnormal blood coagulation function, abnormal liver and kidney function, or other uncontrolled basic diseases (hypertension, diabetes, thyroid disease, etc.) that the researcher access which may affect the progress of the study;
- •history of pelvic malignant tumors;
- •currently participating in other clinical studies;
- •allergic to blood products.
研究组 & 干预措施
autologous decidual-like NK cells
Autologous decidual like NK cells will be isolated and induced in vitro culture from the patients' peripheral blood and perfused into their uterine.
干预措施: autologous decidual-like NK cells (Biological)
结局指标
主要结局
Improvement rate of NK cells
时间窗: 6 months after the first intrauterine infusion therapy
Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
次要结局
- Duration of improvement in NK cells(6 months after the first intrauterine infusion therapy)
- preeclampsia(1 year after completion of NK cells therapy)
- Clinical pregnancy(1 year after completion of NK cells therapy)
- fetal growth restriction(1 year after completion of NK cells therapy)
- Live birth(1 year after completion of NK cells therapy)
- Ongoing pregnancy(1 year after completion of NK cells therapy)