Association Between Interleukin-10 Promoter-1082A/G Polymorphism With Idiopathic Recurrent Miscarriage Risk of Chinese Han
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- genetic polymorphisms associated with idiopathic recurrent miscarriage
研究概览
简要总结
This study aimed to assess the correlation between the interleukin-10 (IL-10)-1082A/G polymorphism and idiopathic recurrent miscarriage (IRM) of Chinese Han. A total of 100 women with IRM and 100 control women with a successful pregnancy will be included in this study. Then genotyping will be performed.
详细描述
As a common occurrence in early pregnancy, IRM has been associated with multiple causes, among which the disorders of immune homeostasis between the fetus and the maternal immune system, maintained by cytokines from the complex regulatory network, are considered one of the potential etiological factors underlying IRM.
The IL-10 polymorphism -1082A/G (rs1800896), which is located in the promoter region of the IL-10 gene, was reported to be implicated in the abnormal expression of IL-10 in IRM by some studies.
However, no such reports about the association between IL-10 polymorphism -1082A/G and IRM risk in Chinese Han.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with more than three consecutive unexplained pregnancy losses before the 20th week;
- •Chinese Han Population;
- •Patients who signed informed consent.
排除标准
- •Patients who had other high-risk factors which might relate with recurrent miscarriage, including: (1) Parental karyotype abnormalities: significant rearrangements (e.g. balanced translocations and mosaics) were considered abnormal. If either the patient (or her partner) had an abnormal karyotype, it was considered a parental karyotypic abnormality; (2) Genital tract abnormalities: Any congenital anatomical deformation of the genital tract was considered abnormal; intrauterine adhesions, endometriosis and hydrosalpinx were also considered abnormal; (3) alloimmune disorder; (4) Endocrine abnormalities: prolactin (PRL) level >25 ng/ml, testosterone level >2.6 nmol/L, thyroid-stimulating hormone level <0.30 mU/L or >4.5 mU/L, free thyroxine (FT4) level <8.36 nmol/L or >29.6 nmol/L and free triiodothyronine (FT3) level <1.84 nmol/L or >7.39 nmol/L. Glucose level > 126mg/dl; (5) Autoimmune disorders: Any positive results of Anti-cardiolipin antibodies (ACA-IgG/IgM/IgA), anti-nuclear antibodies (ANA-IgG), anti-endometrium antibodies (AEA-IgM), anti-ovary antibodies (AOA-IgM), anti-sperm antibodies (ASA-IgM), antithyroidin(TG-Ab), anti-thyroid peroxidase antibody(TPO-Ab) and/or anti-chorionic gonadotropin hormone antibody; (6) Hypercoagulation state: D-dimer levels >260 ng/ml, fibrin degradation products (FDP) levels >5 mg/L or anti-beta 2-glycoprotein I (anti-beta 2-GP1) levels >15 U/ml; (7) Negative RH blood groups; (8) Abnormal semen routine results of patients husband.
- •Patients with serious diseases;
- •Patients with administration of contraceptive pills;
- •Patients participated in other randomized clinical research;
- •Patients could not be followed-up of a long time or had poor compliance;
- •Patients with other factors that would affect the study result.
结局指标
主要结局
genetic polymorphisms associated with idiopathic recurrent miscarriage
时间窗: within one year (plus or minus 1 month) after surgery
Identification of genetic polymorphisms that are associated with idiopathic recurrent miscarriage
次要结局
- Indexes in the routine blood test and blood coagulation test(During pregnancy and three months after miscarriage)