Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Endometrial cytokine LIF concentration (pg/ml)
研究概览
简要总结
Autoimmune diseases cause a decreased endometrial receptivity during the implantation window, most likely changing the endometrial cytokines pattern due to dysregulation of the inflammatory processes.Therefore, endometrial cytokine profiles will be compared in women with autoimmune disease and normal, fertile women.
The collected endometrial tissue and blood samples will be examined for the cytokines profiling using commercially available ELISA kits.
The sample size was calculated choosing, as primary outcome, changes in endometrial LIF concentration between the disease and control Group, which is our main goal. Given a type I error of 5%, a maximum of 21 women are needed for each Group to reach the desired power of 80% to detect the least changes in concentrations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Study group:
- •* Females with infertility combined with autoimmune disease and in fertility treatment.
- •Control group:
- •* Female from couples with severe male infertility and in fertility treatment.
排除标准
- •Language problems to such an extent that the subjects do not understand the scope of the study.
- •Abnormal follicle stimulating hormone (FSH),
- •Abnormal antral follicles Count
- •Genital infections
- •Endometriosis
- •Tubal occlusion
- •Polycystic ovarian syndrome
结局指标
主要结局
Endometrial cytokine LIF concentration (pg/ml)
时间窗: February 18, 2019 - August 31, 2020
The endometrial cytokine LIF profile in endometrial biopsies of women with autoimmune disease will be determined and compared to normal, fertile women (pg/mL)
次要结局
- Blood concentration of cytokines such as LIF, IL6, TNFα TGFα (pg/ml)(February 18, 2019 - August 2020)
- endometrial concentration of cytokines such as, IL6, TNFα TGFα (pg/ml)(February 18, 2019 - August 2020)
研究者
Jens Fedder
Professor, MD, PhD
Odense University Hospital