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

NCT04816357 | Completed

• 1 other identifier: 2021-00285
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 1

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).

Conditions

Endometriosis; Migraine

Outcome Measures

Primary Outcomes (1)

• Endometriosis stage

  endometriosis stage confirmed by laparascopy compared to the control group

  4 years

Secondary Outcomes (5)

• infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations

  4 years

• 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

Study Arms (2)

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

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

Interventions

Questionaire OTHER

only questionaire

Endometriosis; Endometriosis & Migraine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zurich University of Applied Sciences: lead

Study Sites (1)

Universitätsspital Zürich

Zurich, 8008, Switzerland

Location

Related Publications (2)

• Dietrich H, Knobel C, Portmann L, Metzler J, Muendane A, Niggli A, Neumeier MS, Imesch P, Merki-Feld GS. Endometriosis features and dienogest tolerability in women with depression: a case-control study. Eur J Contracept Reprod Health Care. 2023 Jun;28(3):198-204. doi: 10.1080/13625187.2023.2199899. Epub 2023 May 3.

  PMID: 37132337 DERIVED

• Neumeier MS, Pohl H, Dietrich H, Knobel C, Portmann L, Metzler J, Imesch P, Merki-Feld GS. Endometriosis Features in Women With and Without Migraine. J Womens Health (Larchmt). 2023 May;32(5):598-607. doi: 10.1089/jwh.2022.0359. Epub 2023 Mar 10.

  PMID: 36897310 DERIVED

MeSH Terms

Conditions

Endometriosis; Migraine Disorders

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: March 25, 2021
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)