Clinical trial NCT06787365: Questionnaire for the Assessment of Risk Factors Associated with Endometriosis in Adolescent Women with Endometriosis
Official title: Questionnaire for the Assessment of Risk Factors Associated with Endometriosis in Adolescent Women Diagnosed with Endometriosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometriosis
Keywords: Endometriosis
Gynaecology
Questionnaire
Risk factors
Painful symptoms
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with and without a diagnosis of endometriosis

Brief summary: 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

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)

Primary outcomes:
measure: Predictive model of endometriosis onset risk
timeFrame: During the first visit after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Siena
country: Italy
facility: Azienda Ospedaliero-Universitaria Senese
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Simona Del Forno, MD
role: PRINCIPAL_INVESTIGATOR
References: