A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis

A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01351051

Acronym

FEELING

Enrollment

1008

Registered

2011-05-10

Start date

2011-05-31

Completion date

2013-04-30

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief summary

This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 41 Years

Healthy volunteers

Inclusion criteria

* The subject is a female aged between 18 and 41 years * The subject has undergone a laparoscopy or laparotomy for a benign gynecological indication excluding pregnancy, in the last 3 months * The subject's surgery showed either no visible endometriosis lesions or histologically confirmed endometriosis lesions: superficial endometriosis, endometrioma or deep infiltrating endometriosis * The subject has given a written informed consent prior to any study-related procedures

Exclusion criteria

* The subject is pregnant * The subject's surgery results showed evidence of malignancy * The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or with evidence of an uncooperative attitude

Design outcomes

Primary

Measure	Time frame
Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.	Enrolment visit

Secondary

Measure	Time frame
Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.	Enrolment visit
Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.	Enrolment visit
Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.	Enrolment visit

Countries

China, France, Russia

Outcome results