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临床试验/NCT06729359
NCT06729359已完成不适用

Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women

Al-Kindy College of Medicine1 个研究点 分布在 1 个国家目标入组 407 人开始时间: 2024年7月1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
407
试验地点
1
主要终点
the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI

研究概览

简要总结

The goal of this observational case-control study is to find out the impact of PCOS as a risk factor for the presence of urinary tract stones taking into account the BMI of women aged 18-40 years consulting the gynecology and obstetrics outpatient clinic at Al-Elwiya Maternity Teaching Hospital.

The study aims to collect information from approximately 200 women with polycystic ovary syndrome and 200 volunteers who do not have PCOS.

A written consent was obtained from all the participants. The information collected included age, weight, and height. In addition, focused history and clinical examination were conducted for all patients, and for some patients, one or more additional blood tests were obtained. The additional tests included but not limited to serum levels of testosterone, dehydroepiandrosterone sulfate (DHEA-S), androstenedione, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and sex hormone-binding globulin. Moreover, ultrasonography of the abdomen and pelvis was obtained for all patients as part of the diagnosis of PCOS and as screening for urinary tract stones. Also, transvaginal ultrasonography was obtained for some patients according to the individual condition as requested by the treating gynecologist. The diagnosis ofc PCOS was based on the Rotterdam criteria. (1)

The main questions the study aims to answer are:

  • Is PCOS a risk factor for urinary tract stones when taking BMI into account?
  • Is PCOS a risk for urinary tract stones at all?
  • Is there an association between PCOS and BMI?
  • Does BMI affect the presence of urinary tract stones at all and the presence of urinary tract stones when taking PCOS into account?

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age 18-40 years

排除标准

  • A medical or surgical condition that affects urinary tract stone formation.
  • A medical or surgical condition that affects body weight or height.
  • A medical or surgical condition that affects hormonal balance.

结局指标

主要结局

the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI

时间窗: at the time of enrollment

次要结局

  • the association between PCOS (Polycystic Ovary Syndrome) and BMI(at the time of enrollment)
  • the association between BMI and the presence of urinary tract stones(at the time of enrollment)
  • the association between BMI and the presence of urinary tract stones controlled for the presence of PCOS (Polycystic Ovary Syndrome)(at the time of enrollment)

研究者

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

Harth Mohamed Kamber

Assistant proffessor, Consultant utologist

Al-Kindy College of Medicine

研究点 (1)

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