Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism: A Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Free Androgen Index
研究概览
简要总结
This study is a cross-sectional study to explore the endocrine metabolism and inflammatory characteristics of the offspring of mothers with PCOS hyperandrogenism, in order to provide a theoretical basis for finding the cause of PCOS.
详细描述
This study randomly selected 20 women with PCOS and hyperandrogenism who gave birth to a singleton at term at Guangdong Maternal and Child Health Hospital from May 2023 to March 2024, and set them as the HA group. In addition, 22 healthy women were randomly selected as controls. group, the fasting blood glucose (FPG) level of the newborn's peripheral blood and the androgen, fasting insulin and inflammatory factor levels of the newborn's umbilical cord blood were collected respectively.
Among them, the detection indicators of newborn umbilical cord blood include testosterone (T), androstenedione (AND), dehydroepiandrosterone sulfate (DHEA-S), sex hormone binding globulin (SHBG), free androgen index (FAI), Fasting insulin (FINS), white blood cell count (WBC), neutrophil count (NEUT), high-sensitivity C-reactive protein (hs-CRP), and interleukin (IL)-6.
All collected data were statistically analyzed to compare the differences in levels of androgens, fasting insulin, and inflammatory factors in the umbilical cord blood of newborns in the HA group and the control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The diagnosis of polycystic ovary syndrome patients must meet the Rotterdam criteria.
- •Aged between 18 and 45 years old.
- •The gestational age of delivery is between 37 and 41 weeks of gestation.
- •Hyperandrogenemia inclusion criteria: elevated peripheral blood androgens, including testosterone, androstenedione, and dehydroepiandrosterone sulfate.
- •Singleton pregnancy.
- •Signed informed consent form.
排除标准
- •Combined with reproductive organ malformations or chromosomal abnormalities.
- •Combined with chronic diseases such as diabetes and hypertension.
- •Combined with thyroid disease or other serious systemic diseases such as cardiovascular disease.
- •Multiple pregnancy.
- •Combined with congenital adrenal hyperplasia, Cushing's syndrome, hypertension Prolactinoma, and androgen-secreting tumor-related diseases.
结局指标
主要结局
Free Androgen Index
时间窗: Within one year after neonatal cord blood collection.
The free androgen index can reflect the biological activity of androgen.
Interleukin-6
时间窗: Within one year after neonatal cord blood collection.
Interleukin (IL)-6 can be used to assess the inflammatory status.
Sex Hormone Hinding Globulin
时间窗: Within one year after neonatal cord blood collection.
Sex hormone-binding globulin, also known as testosterone-estradiol binding globulin, is a carrier of sex hormones and can reflect the level of sex hormones.
High-sensitivity C-reactive Protein
时间窗: Within six hours of neonatal cord blood collection.
High-sensitivity C-reactive protein can be used to assess the inflammatory status.
Androstenedione
时间窗: Within one year after neonatal cord blood collection.
Androstenedione is one of the androgens, which can be used to assess androgen levels.
Testosterone
时间窗: Within one year after neonatal cord blood collection.
Testosterone is one of the androgens, which can be used to assess androgen levels.
Dehydroepiandrosterone Sulfate
时间窗: Within one year after neonatal cord blood collection.
Dehydroepiandrosterone Sulfate is one of the androgens, which can be used to assess androgen levels.
Fasting Insulin
时间窗: Within one year after neonatal cord blood collection.
Insulin is a hormone secreted by pancreatic beta cells that lowers blood glucose and produces energy metabolism. Its level can assist in the diagnosis of insulin resistance.
White Blood Cell Count
时间窗: Within six hours of neonatal cord blood collection.
The white blood cell count can assess the inflammatory status.
Neutrophil Count
时间窗: Within six hours of neonatal cord blood collection.
Neutrophil count can be used to assess the inflammatory status.
次要结局
未报告次要终点
研究者
Li Li
Deputy Director, Institute of Women's and Children's Health
Guangdong Women and Children Hospital