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

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).

Study Overview

• Status: Completed
• Conditions: Migraine; Endometriosis
• Intervention / Treatment: Other: Questionaire

• Study Type: Observational
• Enrollment (Actual): 344

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • UniversitätsSpital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

From our database of operated endometriosis patients ranging from 2016-2020 100 women will be identified within the first phone call as cases with endometriosis and migraine and the threefold number (n=300) as control with endometriosis only.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endometriosis & Migraine; 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.	Other: Questionaire; only questionaire
Endometriosis; Premenopausal women aged 18-55 years, at time of operation; Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)	Other: Questionaire; only questionaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometriosis stage	endometriosis stage confirmed by laparascopy compared to the control group	4 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zurich University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): November 4, 2021
• Study Completion (Actual): November 4, 2021

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Endometriosis; Migraine Disorders
• Other Study ID Numbers: 2021-00285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No