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

NCT ID: NCT06787365

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-04-30

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

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Study group

Patients with endometriosis

No interventions assigned to this group

Control group

Patients without endometriosis

No interventions assigned to this group

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simona Del Forno, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Azienda Ospedaliero-Universitaria Senese

Siena, Siena, Italy

Countries

Italy

Central Contacts

Simona Del Forno, MD

Role: CONTACT

simona.delforno@aosp.bo.it

+390512143494

Roberto Palermo, MD

Role: CONTACT

roberto.palermo3@studio.unibo.it

Facility Contacts

Simona Del Forno, MD

Role: primary

simona.delforno@aosp.bo.it

+390512143494

Simona Del Forno, MD

Role: backup

Lucia Lazzeri, MD

Role: primary

lazzeri13@unisi.it

+393346887383

Other Identifiers

QuestionENDO

Identifier Type: -

Identifier Source: org_study_id