Quality of Life in Endometriosis - a Case Control Study

NCT02511626 | Completed DMC

• 1 other identifier: Endo_QOL
• Study Type: observational
• Target: 1,267
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis, one of the most common diseases of women during their reproductive period., may present a chronic disabling disease with major impact on women's life. Therapeutic options are limited and recurrence of disease symptoms is frequent. The current study investigates the quality of life and several risk factors for the development of endometriosis as well as satisfaction with medical support in a minimum of 600 women with different stages of endometriosis and the same number of control women matched for age (± 3 years) and nationality. To evaluate specific features of endometriosis-associated pain a second group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places. A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. Questions on sexuality and partnership are also distributed to women's partners. All diagnosis of endometriosis and classification of ASRM (American Society for Reproductive Medicine) disease stages are based on woman's medical charts.

Conditions

Endometriosis; Quality of Life; Pain; Sexuality; Anxiety; Depression; Infertility

Keywords

endometriosis; quality of life; professional activity; pain; infertility; sexuality; partnership; anxiety; depression; stress; childhood trauma; medical support; dyspareunia

Outcome Measures

Primary Outcomes (1)

• Quality of life i.e. pain, infertility, partnership, sexuality, depression, anxiety, stress, medical support, comorbidities and risk factors in the development of endometriosis: childhood trauma, life style factors, menstrual history

  The outcome measures are assessed with internationally validated questionnaires i.e. modified version of the Brief Pain Inventory and Pain Disability Index, modified Form des Childhood Trauma Questionnaire, Brief Symptom Inventory, partnership questionnaire (PFB), modified version of the Brief Index of Sexual Functioning und Global sexual functioning, Hospital Anxiety and Depression Scale (HADS) as well as the questionnaire on life satisfaction (FLZ)

  The questionnaire is answered once after at inclusion in the study, different questions cover different time periods ranging from childhood (0-17 years) to the actual situation (last 4 weeks/ 24hours) as specified in the questionnaire

Secondary Outcomes (2)

• Prevalences of diseases such as dyspareunia, sexual disorders or adverse childhood experiences in the control group.

  Once at inclusion in the study

• Comorbidity of chronic pain.

  Once at inclusion in the study

Study Arms (3)

Case group

Women with a surgically confirmed diagnosis of endometriosis

Control group 1

Women without any evidence of endometriosis (= no clinical symptom and/or no surgical evidence of endometriosis)

Control group 2

Women without endometriosis (surgically confirmed) but chronic abdominal/pelvic pain due to other reasons (e.g. Crohn's disease, colitis etc)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female Age \>18 Case group: women with endometriosis Healthy volunteers in control group

You may qualify if:

• female \>18 years fluent German
• Cases: diagnosis of endometriosis Control 1: no endometriosis, no chronic pain Control 2: no endometriosis, chronic abdominal/pelvic pain

You may not qualify if:

• male (Except for partner questionnaires)
• \<18years
• not fluent in German

Sponsors & Collaborators

• University of Zurich: lead
• Triemli Hospital: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• Kantonsspital Baden: collaborator
• Kantonsspital Winterthur KSW: collaborator
• Kantonsspital Schaffhausen: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital, Aachen: collaborator
• Vivantes Kliniken Berlin: collaborator
• Medical University of Graz: collaborator

Study Sites (1)

Clinic for Reproductive Endocrinology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (7)

• Candan A, Kohl Schwartz A, Birchler K, Leeners B. Psychosomatic comorbidity in endometriosis: A multi-center, cross-sectional study identifying an underestimated factor in current medical support. J Psychosom Res. 2025 Sep;196:112346. doi: 10.1016/j.jpsychores.2025.112346. Epub 2025 Aug 9.

  PMID: 40815907 DERIVED

• El Hadad S, Schwartz ASK, Gassner C, Haeberlin F, von Orelli S, Imesch P, Leeners B. Partnership and relationship happiness in endometriosis related chronic pelvic pain: a multicenter case-control study. Front Psychol. 2024 Oct 14;15:1382067. doi: 10.3389/fpsyg.2024.1382067. eCollection 2024.

  PMID: 39469237 DERIVED

• El-Hadad S, Lasser D, Sachs MK, Schwartz ASK, Haeberlin F, von Orelli S, Eberhard M, Leeners B. Dysmenorrhea in adolescents requires careful investigation of endometriosis-an analysis of early menstrual experiences in a large case-control study. Front Reprod Health. 2023 Aug 25;5:1121515. doi: 10.3389/frph.2023.1121515. eCollection 2023.

  PMID: 37693279 DERIVED

• Sperschneider ML, Hengartner MP, Kohl-Schwartz A, Geraedts K, Rauchfuss M, Woelfler MM, Haeberlin F, von Orelli S, Eberhard M, Maurer F, Imthurn B, Imesch P, Leeners B. Does endometriosis affect professional life? A matched case-control study in Switzerland, Germany and Austria. BMJ Open. 2019 Jan 9;9(1):e019570. doi: 10.1136/bmjopen-2017-019570.

  PMID: 30782670 DERIVED

• Ramin-Wright A, Schwartz ASK, Geraedts K, Rauchfuss M, Wolfler MM, Haeberlin F, von Orelli S, Eberhard M, Imthurn B, Imesch P, Fink D, Leeners B. Fatigue - a symptom in endometriosis. Hum Reprod. 2018 Aug 1;33(8):1459-1465. doi: 10.1093/humrep/dey115.

  PMID: 29947766 DERIVED

• Liebermann C, Kohl Schwartz AS, Charpidou T, Geraedts K, Rauchfuss M, Wolfler M, von Orelli S, Haberlin F, Eberhard M, Imesch P, Imthurn B, Leeners B. Maltreatment during childhood: a risk factor for the development of endometriosis? Hum Reprod. 2018 Aug 1;33(8):1449-1458. doi: 10.1093/humrep/dey111.

  PMID: 29947745 DERIVED

• Kohl Schwartz AS, Wolfler MM, Mitter V, Rauchfuss M, Haeberlin F, Eberhard M, von Orelli S, Imthurn B, Imesch P, Fink D, Leeners B. Endometriosis, especially mild disease: a risk factor for miscarriages. Fertil Steril. 2017 Nov;108(5):806-814.e2. doi: 10.1016/j.fertnstert.2017.08.025.

  PMID: 29079275 DERIVED

MeSH Terms

Conditions

Endometriosis; Pain; Sexuality; Anxiety Disorders; Depression; Infertility; Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior; Mental Disorders; Behavioral Symptoms; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological

Study Officials

• Brigitte Leeners, Prof. Dr.

  Clinic for Reproductive Endocrinology, University Hospital Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 30, 2015
• Study Start: January 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2019
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)