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Questionnaire for the Assessment of Risk Factors Associated with Endometriosis in Adolescent Women with Endometriosis

Observational Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Endometriosis. Basic parameters: 20 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Questionnaire for the Assessment of Risk Factors Associated with Endometriosis in Adolescent Women Diagnosed with Endometriosis

Overview

A number of risk factors that may be associated with endometriosis in adolescents (medical history and symptoms) are reported in the literature, but no overall estimate of disease risk has been developed. Providing a tool for assessing risk factors associated with endometriosis in adolescents by estimating disease risk could aid the clinician in diagnosis and reduce diagnostic delay

Detailed description

Although more than 60% of adult women with endometriosis report that their painful symptoms appeared before the age of 20, early diagnosis, particularly in adolescent girls, is still a challenge for doctors. The reasons for this delay include inadequate knowledge of the disease among healthcare professionals, the social and health normalisation of menstrual pain, and the peculiar aspects of the disease in adolescent patients. The adolescent patient with endometriosis presents particular anamnestic, familial and personal risk factors, as well as peculiar symptoms such as non-specific abdominal pain, acyclic pelvic pain, gastrointestinal symptoms, migraine, in addition to those classically reported in adulthood.

It may therefore be useful to identify a predictive model of the onset of endometriosis based on the risk factors currently recognised in the literature (anamnestic data) and on the results of a questionnaire to be submitted to adult women (aged between 20 and 50 years), with endometriosis (group 1) and without a diagnosis of endometriosis (group 2), concerning symptoms experienced in adolescence

Primary outcome measures

  • Predictive model of endometriosis onset risk [Time frame: During the first visit after enrollment]

Eligibility criteria

Inclusion criteria

  • Women of childbearing age between 20 and 50 years
  • Clinical and ultrasound diagnosis of endometriosis for the study group and exclusion of endometriosis for the control group (examination and ultrasound performed according to the IDEA study criteria)
  • Acquisition of informed consent for participation in the study and processing of personal data

Exclusion criteria

\- Women suffering from other conditions responsible for pelvic pain (uterine fibromatosis, current or previous pelvic inflammatory disease, ovarian cysts of a non-endometriotic nature, irritable bowel syndrome, inflammatory bowel disease, interstitial cystitis)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 2 centers
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
  • Azienda Ospedaliero-Universitaria Senese — Siena

Identifiers

NCT: NCT06787365 · QuestionENDO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗