IRCT20080831001141N43招募中1 期
Safety and feasibility study of intra-ovarian injection of bone marrow mesenchymal stromal cells-derived extracellular vesicles in idiopathic premature ovarian failure patients: Clinical trial phase I
otus Royan Charitable Fundation0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 years 至 38 years（—）
- 性别
- Female
入选标准
- •Women between 20-38 years old
- •Baseline serum level of follicle stimulating hormone (FSH) higher or equal to 25 IU/l at least twice with an interval of 3 or 4 months
- •At least one year has passed since secondary amenorrhea and premature ovarian failure (POF) diagnosis
- •Normal karyotype and fragile X messenger ribonucleoprotein 1 (FMR1) gene
排除标准
- •Primary amenorrhea
- •Congenital anomaly of the ovary
- •Thyroid disease
- •Immune system diseases such as lupus and...
- •Previous and/or family history of ovarian tumor
- •Previous and/or family history of suffering from major diseases in the past and present such as cancer
- •Positive serological evidence regarding previous or current hepatitis B and C, Human T-lymphotropic virus 1, Human immunodeficiency virus (HIV), Syphilis
- •Disturbance in the normal range of laboratory tests as levels of Hemoglobin Subunit Alpha 1 (HbA1), Alanine transaminase (ALT), The aspartate aminotransferase (AST), the number of white blood cells (WBCs), The creatinine (Cr), International normalised ratio (INR) , Platelets (Plt), Hematocrit (Hct) tests.
- •History of specific systemic disease (rheumatology, endocrine, cardiovascular, etc.)
- •Severe endometriosis (stage III and IV)
- •Small and non-injectable ovaries
- •Lack of patient satisfaction
- •The patient's unwillingness to continue participating in the plan
研究者
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