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

January 15, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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

Study Overview

Status

Not yet recruiting

Conditions

Endometriosis

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

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Simona Del Forno, MD
Phone Number: +390512143494
Email: simona.delforno@aosp.bo.it

Study Contact Backup

Name: Roberto Palermo, MD
Email: roberto.palermo3@studio.unibo.it

Study Locations

Italy
- - Bologna, Italy, 40138
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
    - Contact:
      
      Simona Del Forno, MD
      
      Phone Number: +390512143494
      
      Email: simona.delforno@aosp.bo.it
    - Contact:
      
      Simona Del Forno, MD
  - Siena, Italy, 53100
    - Azienda ospedaliero-universitaria Senese
    - Contact:
      
      Lucia Lazzeri, MD
      
      Phone Number: +393346887383
      
      Email: lazzeri13@unisi.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with and without a diagnosis of endometriosis

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Study group Patients with endometriosis
Control group Patients without endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive model of endometriosis onset risk Time Frame: During the first visit after enrollment	Predictive model of the occurrence of endometriosis based on the risk factors currently recognised in the literature (anamnestic data) and the results of a questionnaire consists of 28 multiple-choice questions, concerning symptoms experienced in adolescence	During the first visit after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Simona Del Forno, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)