Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- LH value
研究概览
简要总结
This is an observational, retrospective, single-center study focused on the diagnosis of Central Precocious Puberty in female patients.
详细描述
The study enrolls female patients undergoing GnRh testing for suspected diagnosis of Central Early Puberty between january 2017 and December 2020 at the Pediatrics Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola.
The study design provides 2 cohorts of female patients on the basis of the LH peak value in GnRH test: patients with LH peak value < 5U/L, and patients with LH peak value > 5U/L.
The primary aim is to assess the diagnostic power of basal LH comparing with the LH peak value after stimulus test with GnRH in female patients with suspected precocious puberty. The secondary aim is to assess the association of the following variables between the two cohorts: uterine volume, longitudinal uterine diameter, presence of endometrial rhyme, ratio of peak LH/FSH values and dose per kg of GnRH administered during stimulus test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 8 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with onset of signs of early pubertal development (onset of telarche) before the age of 8 years, who referred to the Pediatrics Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola between January 2017 and December 2020;
- •Female patients undergoing GnRh testing for suspected diagnosis of Central Early Puberty between january 2017 and December 2020;
- •Obtaining informed consent from parents/legal guardian of pediatric patients.
排除标准
- •Patients with Peripheral precocious puberty.
结局指标
主要结局
LH value
时间窗: at baseline
basal Lh value, and LH peak value after stimulus test with GnRH (mU/mL )
次要结局
- Uterine volume(at baseline)
- Longitudinal uterine diameter(at baseline)
- Presence of endometrial rhyme(at baseline)
- Ratio of peak LH/FSH values(at baseline)
- peak LH (mU/mL) value / FSH value ( mU/mL)(at baseline)