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

February 7, 2022 updated by: Hanna Dietrich, Zurich University of Applied Sciences

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

344

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8008
        • Universitatsspital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zurich University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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