Androgen Metabolism and Reproductive Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- correlation of testosterone between mother and offspring
研究概览
简要总结
The aim of this study is to determine maternal androgen metabolism during pregnancy and the impact of androgen disorders on mothers and infants.
详细描述
Women with polycystic ovary syndrome (PCOS) have an impaired fertility and significant higher complication rates during infertility treatment, pregnancy and the perinatal period. Complications include the occurrence of multiple gestations, ovarian hyper stimulation syndrome, early pregnancy loss, gestational diabetes, pregnancy-induced hypertension, pre-eclampsia and need for caesarean section. Moreover, their infants are more frequently born preterm, have higher perinatal mortality rates and are more often admitted to a neonatal intensive care unit. The etiology of PCOS is not particularly mapped, but a genetic background can be assumed by analyzing PCOS families. In utero androgen excess has also been suspected to be an important risk factor. Animal studies have demonstrated that intrauterine hyperandrogenic environment affects the offspring by leading to biochemical and morphological features of PCOS. Sex differences in prenatal androgen levels have been observed and testosterone levels in umbilical cord blood and in amniotic fluid are higher in healthy male babies than in healthy female babies. There are just a few reporting on the relation between maternal androgen levels during pregnancy and the respective offspring. The aim of this clinical study is to determine maternal androgen metabolism and the impact of androgen disorders on mothers and infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •pregnant women with and without PCOS
排除标准
- •unable to consent
结局指标
主要结局
correlation of testosterone between mother and offspring
时间窗: day of birth (within average 24 hours)
次要结局
- maternal sexual hormon binding globulin(six weeks after birth)
- correlation of human growth hormon between mother and offspring(day of birth (within average 24 hours))
- correlation of cortisol between mother and offspring(day of birth (within average 24 hours))
- correlation of prolactin between mother and offspring(day of birth (within average 24 hours))
- correlation of sexual hormon binding globulin between mother and offspring(day of birth (within average 24 hours))
- correlation of thyroid-stimulating hormone between mother and offspring(day of birth (within average 24 hours))
- correlation of progesterone between mother and offspring(day of birth (within average 24 hours))
- correlation of dehydroepiandrosteron between mother and offspring(day of birth (within average 24 hours))
- correlation of follicle stimulating hormone between mother and offspring(day of birth (within average 24 hours))
- correlation of estrogen levels between mother and offspring(day of birth (within average 24 hours))
- maternal androstendione(six weeks after birth)
- maternal progesterone(six weeks after birth)
- maternal insulin(six weeks after birth)
- maternal human growth hormon(six weeks after birth)
- correlation of insulin between mother and offspring(day of birth (within average 24 hours))
- correlation of c-peptide between mother and offspring(day of birth (within average 24 hours))
- maternal follicle stimulating hormone(six weeks after birth)
- correlation of androstendione between mother and offspring(day of birth (within average 24 hours))
- correlation of luteinizing hormon between mother and offspring(day of birth (within average 24 hours))
- maternal thyroid-stimulating hormone(six weeks after birth)
- maternal cortisol(six weeks after birth)
- maternal luteinizing hormon(six weeks after birth)
- maternal estrogen levels(six weeks after birth)
- maternal testosterone(six weeks after birth)
- correlation of anti muellerian hormon between mother and offspring(day of birth (within average 24 hours))
- correlation of Vitamin D levels between mother and offspring(day of birth (within average 24 hours))
- maternal anti muellerian hormon(six weeks after birth)
- maternal dehydroepiandrosteron(six weeks after birth)
- maternal c-peptide(six weeks after birth)
- maternal Vitamin D levels(six weeks after birth)
- maternal prolactin(six weeks after birth)