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临床试验/NCT03859856
NCT03859856已完成不适用

Ovarian Reserve in Patients With Type 1 Diabetes Mellitus

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
antral follicle count

研究概览

简要总结

Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. Hyperglycemic condition in diabetes can cause organ damage. This study aims to measure serum hormones including FSH, LH, E2, AMH, ovarian volume and antral follicle count (indicators of ovarian reserve) in women with and without type 1 diabetes mellitus.

详细描述

Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. It is showed that hyperglycemic state in diabetes results in organ damage like kidneys and eyes. Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients diagnosed with type 1 diabetes mellitus and to compare them to healthy controls. Serum FSH, LH, E2 and AMH will be measured on the 3rd day of the cycle. Antral follicle count and ovarian volume measurement will be done with ultrasonography. Ovarian reserve markers will be compared between the groups.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Reproductive age group women: 18-40 years
  • Women diagnosed with type 1 diabetes (case group)
  • Women without type 1 diabetes (control group)

排除标准

  • Women with PCOS (polycystic ovary syndrome)
  • history of ovarian surgery
  • Body mass index (BMI) over 30

结局指标

主要结局

antral follicle count

时间窗: during procedure

antral follicles of ovaries will be counted with ultrasonography

E2, FSH, LH, AMH levels

时间窗: during procedure

E2, FSH, LH, AMH levels of blood samples will be measured

ovarian volume

时间窗: during procedure

both ovaries will be measured in three dimensions with ultrasonography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Aslan Cetin

Md, ObGYN

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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