NL-OMON37641撤回不适用
The Cycle disturbances, OLigomenorrhea and Amenorrhea (COLA) Study - COLA
Voortplantingsgeneeskunde0 个研究点目标入组 4,000 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •Hypogonadotropic hypoestrogenic status (previously: *hypothalamic amenorrhea*)
- •1. Low to normal serum FSH concentrations
- •2. Low serum estradiol concentrations;WHO II
- •1. Amenorrhea or oligomenorrhea (mean cycle >35 days during the last 6 months)
- •2. Normal serum FSH concentrations (<12 IU/L)
- •3. Absence of other causes for the cycle disturbance, including: normal prolactin
- •concentrations (<1.0 IU/L), normal TSH concentrations (0.2 * 4.2 mU/L), abnormalities on
- •ultrasonography.;Within women with WHO II status, PCOS is diagnosed when at least 2 of the following
- •criteria are met:
- •1. Oligo-/anovulation
- •2. Clinical and/ or biochemical hyperandrogenism
- •3. Polycystic ovaries on ultrasonography;WHO III
- •1. POI: defined as secondary amenorrhea before the age of 40 years and basal FSH > 40
- •2. IOF: defined as normo-ovulatory cycles with raised basal FSH > 12 IU/L before the age of
- •3. TOF: defined as irregular cycles with raised basal FSH > 12 IU/L before the age of 40
- •4. 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.
- •5. Early menopause: menopause occurring between age 40 and 45 years.
- •6. Hypergonadotropic primary amenorrhea: primary amenorrhoea with raised basal FSH > 12
- •IU/L.;When a familial component can be identified from the family history (i.e. * 3 affected relatives), the 1st and/or 2nd degree relatives will be approached for participation in the genetic screening. (for procedure; see question F1)
排除标准
- •- Age: younger than 12 yrs.
- •- Regularly cycling women, with the exception of women with elevated basal FSH concentrations (IOF cases).
- •- Hypergonadotropic primary amenorrhea caused by early development disorders causing absence of ovaries and Swyer syndrome (XY).
研究者
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