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

January 11, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1008

Contacts and Locations

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

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
      • Beijing, China
        • Peking Union Medical College Hospital
      • Changsha, China
        • The Third Xiangya Hospital of Central South University
      • Zhejiang, China
        • Women's Hospital School of Medicine, Zhejiang University
  • France
      • Paris, France
        • Hôpital St Vincent de Paul
  • Russian Federation
      • Ivanovo, Russian Federation
        • Research Institute of Maternity and Childhood named after V.N. Gorodkov
      • Moscow, Russian Federation
        • Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology

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

14 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women who have undergone a laparoscopy/laparatomy for a benign gynaecological indication excluding pregnancy in the last 3 months.

Description

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
No endometriosis
Superficial endometriosis
Endometrioma
Deep infiltrating endometriosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 8, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-38-52014-185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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