Global Study of Women's Health
Condition: Endometriosis; Infertility; Chronic Pelvic Pain; Tubal Ligation
MeSH terms: Infertility; Endometriosis; Pelvic Pain
Study type: Observational

Summary: 
      Endometriosis, a condition in which the lining of the uterus grows on nearby tissues, is a
      common condition that affects women of reproductive age worldwide. The diagnosis of
      endometriosis is usually made at surgery. The most common symptom is pelvic pain. This pain
      may occur at the same time as menstrual bleeding, at other times of the cycle, or during or
      after sexual intercourse. Previous studies reveal the diagnosis of endometriosis is often
      delayed between 8 and 12 years after the first symptoms. Women with chronic pelvic pain
      report a lower quality of life. No studies, however, have been conducted to assess whether
      women with endometriosis-related pelvic pain are affected differently than those with pelvic
      pain from other or no identifiable causes.

      This large-scale study is designed to gather prospective epidemiological data on the impact
      of and risk factors for endometriosis across countries worldwide. A study of this scale and
      scope has never been performed; it is anticipated that the study will provide novel insights
      into the effects of the condition and associated symptoms on women s lives across different
      countries, as well as explore differences in the effects of various potential risk factors.

      This is an international study conducted at more than 20 sites worldwide and coordinated by
      Oxford University in the United Kingdom. At the National Institutes of Health, 250
      premenopausal women between 18 and 45 years of age who are having their first diagnostic
      laparoscopy or laparoscopy for tubal sterilization will participate. None will have had a
      prior diagnosis of endometriosis through surgery. Women will be informed about the study when
      their laparoscopy is scheduled.

      Procedures

        -  Patient completion of an online questionnaire before scheduled surgery. The following
           will be assessed by the questionnaire:

        -  Quality of life

        -  General gynecologic and medical history

        -  Family history

        -  General information

        -  Use of health care services

        -  Risk factors

        -  Surgeon completion of questionnaire about surgical findings.

        -  Follow-up: Women who consent will be contacted every 1 2 years.
    

Detailed description: 
      This large-scale study is designed to gather prospective epidemiological data on the impact
      of and risk-factors for endometriosis across countries world-wide. A study of this scale and
      scope has never been performed; it is anticipated to provide novel insights into the effects
      of the condition and associated symptoms on women s lives across different countries, as well
      as explore (differences in) the effects of various potential risk-factors.

      Study Design: This is a clinic-based patient survey of prospectively recruited women
      undergoing a laparoscopy for symptoms suggestive of endometriosis or for tubal sterilization.
      Descriptive, as well as nested case-control studies will be conducted using information
      collected from patients in the registry to investigate the impact of endometriosis and
      associated symptoms, and test etiological hypotheses.

      Primary Outcome: The primary purpose of this survey is to collect systematic, comprehensive
      epidemiological information on the impact of endometriosis among women world-wide, in terms
      of prevalence, diagnostic delay, quality of life, economic effect indicators, health care
      utilization, and risk-factors.

      Secondary Outcomes: A secondary purpose of the register is to provide a frame-work for future
      follow-up studies of women diagnosed with endometriosis, allowing the investigation of
      indicators of effectiveness of different treatment options; long-term quality of life issues,
      as well as personal and economic (productivity) costs of endometriosis. The multi-center
      nature of the study should allow variability of endometriosis illness outcomes and
      associations to be assessed across participating countries.

      Statistical Methods:

      Basic descriptive analyses will include prevalence estimates according to different age and
      demographic characteristics, across countries. The analyses of most outcomes will be
      conducted by comparing women with endometriosis (cases) to those without (controls), both of
      which will have been recruited through the same process. To avoid bias, cases will be matched
      to controls on characteristics such as age, country of residence and clinic attended. The
      analysis of the data will take into consideration this matching; in addition, adjustment for
      symptoms for which the laparoscopy was indicated (pelvic pain, infertility) will be included.
      Continuous variables and categorical variables will be analyzed with the appropriate
      statistical tests.

      Duration of Patient Participation: Women are informed about the study at the consultation
      during which their laparoscopy is scheduled. If they accept to participate, they are asked to
      fill in an online questionnaire any time before their scheduled surgery. Unless they consent
      to being contacted sometime in the future for follow-up surveys, their active participation
      in the study ends. If they wish to participate in future surveys, they will be contacted at
      most every 1-2 years.
    

Time perspective: Prospective
Keywords: Endometriosis; Infertility; Tubal Ligation; Chronic Pelvic Pain; Quality of Life