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

Completed

• Conditions: Migraine; Endometriosis
• Interventions: Other: Questionaire

• Registration Number: NCT04816357
• Lead Sponsor: Zurich University of Applied Sciences

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study Start: 2021-03-25
• Study First Posted: 2021-03-25
• Primary Completion: 2021-11-04
• Study Completion: 2021-11-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 344

Inclusion Criteria

• 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.

Exclusion Criteria

• Inability to perform the interview (insufficient knowledge of language, psychological disorder, dementia)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometriosis	Questionaire	* Premenopausal women aged 18-55 years, at time of operation * Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)
Endometriosis & Migraine	Questionaire	* 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.

Primary Outcome Measures

Name	Time	Method
Endometriosis stage	4 years	endometriosis stage confirmed by laparascopy compared to the control group

Secondary Outcome Measures

Name	Time	Method
and age of first symptoms for both conditions and age at first operation	4 years	s.o.
family history with first-degree relatives,	4 years	s.o.
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	s.o.
response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted	4 years	s.o.
infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations	4 years	s.o.

Trial Locations

Locations (1)

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland