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

NCT06787365 | Not Yet Recruiting

• 1 other identifier: QuestionENDO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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

Conditions

Endometriosis

Keywords

Endometriosis; Gynaecology; Questionnaire; Risk factors; Painful symptoms

Outcome Measures

Primary Outcomes (1)

• Predictive model of endometriosis onset risk

  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

Study Arms (2)

Study group

Patients with endometriosis

Control group

Patients without endometriosis

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with and without a diagnosis of endometriosis

You may qualify if:

• Women of childbearing age between 20 and 50 years
• Acquisition of informed consent for participation in the study and processing of personal data

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Azienda Ospedaliero-Universitaria Senese

Siena, Siena, 53100, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Simona Del Forno, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Del Forno, MD

CONTACT

+390512143494; simona.delforno@aosp.bo.it

Roberto Palermo, MD

CONTACT

roberto.palermo3@studio.unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 22, 2025
• Study Start: February 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-10

Locations

IT (2)