Ultrasound Assessment of Uterine and Endometrium Volume in Women With PCOS and HPOD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 648
- 试验地点
- 1
- 主要终点
- Uterine volume
研究概览
简要总结
Group II causes of anovulation according to the World Health Organization include polycystic ovary syndrome (PCOS) and the less common dysfunction of the hypothalamic-pituitary-ovarian axis (HPOD). Assessment of ovarian volume, number and morphology of ovarian follicles is essential in the diagnosis of menstrual disorders, including PCOS and HPOD. However, the uterus is a target organ for steroid hormones, and the assessment of uterine size and endometrial morphology may also be of clinical importance. While ultrasonographic features of the ovaries in PCOS have been described and constitute one of the diagnostic criteria for the syndrome (Rotterdam criteria), there is little data on uterine volume in women with PCOS and HPOD. The aim is to compare ultrasound i) uterine volume and ii) endometrial volume among women with PCOS and women with HPOD.
详细描述
Group II causes of anovulation according to the World Health Organization include polycystic ovary syndrome (PCOS) and the less common dysfunction of the hypothalamic-pituitary-ovarian axis (HPOD). The exact etiology of both entities is unknown. The diagnosis of PCOS requires meeting the Rotterdam criteria. HPOD, in turn, is considered a functional disorder of the axis, related to lifestyle factors, and the diagnosis is made after excluding identifiable causes of ovulation disorders. Assessment of ovarian volume, number and morphology of ovarian follicles is essential in the diagnosis of menstrual disorders, including PCOS and HPOD. However, the uterus is a target organ for steroid hormones, and the assessment of uterine size and endometrial morphology may also be of clinical importance. The dimensions and volume of the uterus and endometrium may influence the clinical pregnancy rate in women undergoing assisted reproductive technologies. Both too small and too large sizes and volumes of the uterus may reduce the rate of clinical pregnancies. Too small dimensions may result from hypoestrogenism, while excessive size may be the result of estrogen-progesterone imbalance accompanying PCOS, increased uterine vascularity, as well as estrogen-dependent changes in the uterine myometrium, such as adenomyosis. Similarly, too "thin" endometrium and too thick (cystic) endometrium may reduce the receptivity of the endometrium. While ultrasonographic features of the ovaries in PCOS have been described and constitute one of the diagnostic criteria for the syndrome (Rotterdam criteria), there is little data on uterine volume in women with PCOS and HPOD. The aim is to compare ultrasound uterine volume and endometrial volume among women with PCOS and women with HPOD. The volume of the uterus will be determined according to the formula: V = (π/6) × length × width × height (in cm and given in ml). The volume of the endometrium will also be measured according to a similar formula.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •age 18-45 years
- •no previous diagnosis and treatment due to menstrual disorders or infertility
排除标准
- •previous ovarian surgery
- •use of drugs that disturb the functions of the hypothalamic-pituitary-ovarian axis
- •uterine tumors
研究组 & 干预措施
Arm 1
Polycystic ovary syndrome (PCOS)
干预措施: Two-dimensional and three-dimensional ultrasound of the female reproductive organ (Diagnostic Test)
Arm 2
Hypothalamic-pituitary-ovarian axis dysfunction (HPOD)
干预措施: Two-dimensional and three-dimensional ultrasound of the female reproductive organ (Diagnostic Test)
结局指标
主要结局
Uterine volume
时间窗: 12 months
Comparison of uterine volume in ml calculated using the presented formula in both arms of the study
Endometrium volume
时间窗: 12 months
Comparison of endometrial volume in ml calculated using the presented formula in both arms of the study
次要结局
未报告次要终点
研究者
Iwona Magdalena Gawron
PhD, MD
Jagiellonian University
