NCT05520112Unknown1 期
Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells Capable of Differentiation in the Endometrial-decidual Direction
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse effects associated with the therapy
研究概览
简要总结
Treatment of Recurrent pregnancy loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.
详细描述
Treatment of Recurrent pregnancy (characterized by the presense of thin endometrium) loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients of reproductive age 18-49 years;
- •recurrent pregnancy loss without current pregnancy with thin endometrium;
- •unsuccessful IVF cycles due to thin endometrium;
- •endometrial thickness is ≤6 mm in the first and second phases of the menstrual cycle;
- •uterine infertility associated with endometrial hypoplasia;
- •the absence of genetic diseases that prevent pregnancy;
- •absence of taking hormonal drugs for 3 months prior to enrollment in the study.
排除标准
- •patients with congenital malformations of the genital organs: agenesis and aplasia of the uterus, bicornuate uterus, unicornuate uterus, congenital fistula between the uterus and the digestive and urinary tracts, other congenital anomalies of the body and cervix. congenital anomaly of the body and cervix, unspecified, other specified developmental anomalies;
- •acute inflammatory processes in the uterus;
- •acute or chronic infectious and non-infectious diseases in the acute stage, including HIV, hepatitis B and C, syphilis, tuberculosis, chlamydia, myco-, ureaplasmosis, herpes, toxoplasmosis, rubella, cytomegalovirus, gonorrhea, trichomoniasis, etc.;
- •autoimmune diseases;
- •patients with malignant tumor including a history;
- •patients with benign tumors of the uterus and appendages;
- •miscarriage not associated with a thin endometrium, including immunological origin;
- •hyper- or hypogonadotropic insufficiency of ovarian function, hyperandrogenemia of any origin;
- •allergic reactions in the acute stage, established hypersensitivity to any component of the biomedical cell product;
- •permanent therapy with cytostatics, hormones;
- •mental and behavioral disorders that make it impossible for patients to participate in the study, drug and/or alcohol addiction.
结局指标
主要结局
Adverse effects associated with the therapy
时间窗: 1 month
Determination of adverse effects associated with the therapy
Percent of patients with successful pregnancy
时间窗: 1 year
Percent of patients with successful pregnancy within 1 year after treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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