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临床试验/NCT06545994
NCT06545994招募中不适用

A Prospective Cohort Study on the Dynamic Monitoring of Serum Kisspeptin Levels Throughout Pregnancy and Exploring Its Predictive Value for Gestational Diabetes Mellitus in PCOS Patients

Fudan University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients

研究概览

简要总结

The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.

详细描述

The current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (PCOS) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for GDM and other complications in PCOS patients.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 18 and 40 years old
  • Women diagnosed as PCOS who register for prenatal check ups in the obstetrics outpatient department of hospitals during early pregnancy.(The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria (any two out of the three key characteristics of PCOS: oligo-amenorrhea, hyperandrogenism, and polycystic-appearing ovarian morphology on ultrasonography) .

排除标准

  • All other diseases with ovulation disorders or hyperandrogenism

结局指标

主要结局

Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients

时间窗: 40 weeks

Serum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group.

次要结局

  • The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients(40 weeks)
  • The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients(40 weeks)

研究者

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

Zhang Wei

Professor, Ph.D

Fudan University

研究点 (1)

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