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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

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ClinicalTrials.gov Identifier: NCT04816357
Recruitment Status : Completed
First Posted : March 25, 2021
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Hanna Dietrich, Zurich University of Applied Sciences

Study Description
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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).


Condition or disease Intervention/treatment
Endometriosis Migraine Other: Questionaire

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 344 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: 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
Actual Study Start Date : March 25, 2021
Actual Primary Completion Date : November 4, 2021
Actual Study Completion Date : November 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Endometriosis stage [ Time Frame: 4 years ]
    endometriosis stage confirmed by laparascopy compared to the control group


Secondary Outcome Measures :
  1. infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations [ Time Frame: 4 years ]
    s.o.

  2. and age of first symptoms for both conditions and age at first operation [ Time Frame: 4 years ]
    s.o.

  3. family history with first-degree relatives, [ Time Frame: 4 years ]
    s.o.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816357


Locations
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Switzerland
Universitätsspital Zürich
Zürich, Switzerland, 8008
Sponsors and Collaborators
Zurich University of Applied Sciences
More Information
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Responsible Party: Hanna Dietrich, Investigator, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier: NCT04816357    
Other Study ID Numbers: 2021-00285
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Endometriosis
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases