The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- hormonal classification
研究概览
简要总结
Through the COLA Study and Biobank the investigators hope to enable further identification of phenotype, endocrine, ethnic, and metabolic characteristics associated with menstrual cycle disturbances; and: the identification of genetic or other etiologic factors associated with cycle disturbances.
详细描述
Population Women with cycle disturbances are referred to the outpatient clinic specialized in cycle disturbances by 1st or 2nd line care providers for further diagnostic procedures.
Inclusion criteria WHO I Hypogonadotropic hypoestrogenic status (previously: "hypothalamic amenorrhea")
- Low to normal serum follicle-stimulating hormone (FSH) concentrations
- Low serum estradiol concentrations
WHO II
- Amenorrhea or oligomenorrhea (mean cycle >35 days during the last 6 months)
- Normal serum FSH concentrations (<12 IU/L)
- Absence of other causes for the cycle disturbance, including: normal prolactin concentrations (<1.0 IU/L), normal thyroid stimulating hormone (TSH) concentrations (0.2 - 4.2 milli-International unit /L), abnormalities on ultrasonography.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •WHO I Hypogonadotropic hypoestrogenic status (previously: "hypothalamic amenorrhea")
- •Low to normal serum FSH concentrations
- •Low serum estradiol concentrations
- •Amenorrhea or oligomenorrhea (mean cycle >35 days during the last 6 months)
- •Normal serum FSH concentrations (<12 IU/L)
- •Absence of other causes for the cycle disturbance, including: normal prolactin concentrations (<1.0 IU/L), normal TSH concentrations (0.2 - 4.2 milliunits/L), abnormalities on ultrasonography.
- •Within women with WHO II status, PCOS is diagnosed when at least 2 of the following criteria are met:
- •Oligo-/anovulation
- •Clinical and/ or biochemical hyperandrogenism
- •Polycystic ovaries on ultrasonography
- •POI: defined as secondary amenorrhea before the age of 40 years and basal FSH > 40 IU/L.
- •IOF: defined as normal ovulatory cycles with raised basal FSH > 12 IU/L before the age of 40 years.
- •TOF: defined as irregular cycles with raised basal FSH > 12 IU/L before the age of 40 years.
- •Poor ovarian response: defined as less than 4 oocytes retrieved or cancellation in case of absent follicle growth after ovarian hyperstimulation with 300 IU gonadotropins.
- •Early menopause: menopause occurring between age 40 and 45 years.
- •Hypergonadotropic primary amenorrhea: primary amenorrhea with raised basal FSH > 12 IU/L.
- •Exclusion criteria: Exclusion criteria
- •Age: younger than 18 yrs.
- •Regularly cycling women, with the exception of women with elevated basal FSH concentrations (IOF cases).
排除标准
- 未提供
结局指标
主要结局
hormonal classification
时间窗: within 6 weeks
FSH, LH, Estradiol, Progesterone,Testosterone, Androstenedione, Sex hormone binding globulin (SHBG), Cortisol, TSH
metabolic profile
时间窗: within 6 weeks
total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, insulin, glucose
ovarian reserve
时间窗: within 6 weeks
anti mullerian hormone, FSH and antral follicle count.
次要结局
- autoimmunity in WHO 3- POI patients(within 3 months)
- bone density in WHO 3- POI patients(within 3 months)
- genotype in WHO 3 POI patients(within 3 months)
研究者
Bart CJM Fauser
professor BCJM Fauser
UMC Utrecht