Identification of Endometriosis and Migraine Criteria in Women With the Comorbidity of Both Conditions in Comparison With Women Who Only Suffer From Endometriosis - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Endometriosis stage
研究概览
简要总结
Patients with both, migraine and endometriosis, present the case-group, while women with endometriosis without migraine serve as controls. The primary endpoint is endometriosis stage confirmed by laparascopy compared to the control group. Further points to compare between groups are infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations, family history with first-degree relatives, and age of first symptoms for both conditions and age at first operation.
Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response, response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted as well as response to Dienogest treatment.
In the questionnaire we will ask 62 Questions overall. The Questions for endometriosis are based on a questionnaire from the world endometriosis research foundation and to evaluate the severity of the migraine we will use the MIDAS (Migraine Disability Assessment) questionnaire (8).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women aged 18-55 years, at time of operation
- •Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)
- •For the cases migraine needs to be confirmed during the interview according to the IHS criteria.
排除标准
- •Inability to perform the interview (insufficient knowledge of language, psychological disorder, dementia)
结局指标
主要结局
Endometriosis stage
时间窗: 4 years
endometriosis stage confirmed by laparascopy compared to the control group
次要结局
- and age of first symptoms for both conditions and age at first operation(4 years)
- family history with first-degree relatives,(4 years)
- Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response,(4 years)
- response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted(4 years)
- infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations(4 years)
研究者
Hanna Dietrich
Investigator
Zurich University of Applied Sciences