Proliferative Effects of Erythropoietin on Human Endometrium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change from Baseline Endometrial Thickness Confirmed by Transvaginal Ultrasonography at 3th and 30th Days
研究概览
简要总结
The purpose of this study to assess the proliferative effects of erythropoetin on human endometrium tissue by measuring the endometrial thickness, uterine artery and subendometrial blood flow in postmenopausal women.
详细描述
20 postmenopausal women who are planned to treat with erythropoietin alpha for their renal conditions will be included to the study. Sample size was calculated with proper power analysis with accepting the difference of 1 mm in endometrial thickness as a significant change. After the informed consent, endometrial thickness (mm), uterine artery and subendometrial blood flow by doppler ultrasonography (RI, S/D) will be measured. Same measurements will be repeated on the 3rd day and 30th day. Patients' age, BMI, co-morbidities, administered erythropoietin doses will be noted. No adverse effect is expected with regard to the ultrasonographic examination. Date of the patients who do not attend for the appointments for repetitive examinations and uninterpretable doppler variables due to the atrophic uterus will be noted as the missing data and will be excluded from the study. Proper statistical analysis will be done.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically condition with need for erythropoietin treatment such as anemia due to the renal failure or the need for hemodialysis.
- •Must be in postmenopausal period
排除标准
- •Patients with any type of malignancy
- •Existence of any intracavitary mass which may affect endometrial thickness or blood flow such as endometrial polyps, myomas, intracavitary fluid etc.
- •Intrauterine device
- •Being on Hormon replacement therapy
- •Hysterectomized patients
研究组 & 干预措施
Erythropoietin
Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml, three times in a week, until the correction of anemia, approximately two months.
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Change from Baseline Endometrial Thickness Confirmed by Transvaginal Ultrasonography at 3th and 30th Days
时间窗: within the first 3 and 30 days (plus or minus 3 days) after the erythropoietin treatment
Change from Baseline Endometrial Thickness Confirmed by Transvaginal
次要结局
未报告次要终点
研究者
MEHMET AKIF SARGIN
Principal Investigator
Fatih Sultan Mehmet Training and Research Hospital