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Completed

NCT Number: NCT01351051

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

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Key information

Conditions

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

Age range

18 year–41 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking Union Medical College Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.

    Time frame: Enrolment visit

Secondary outcomes

  1. Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.

    Time frame: Enrolment visit

  2. Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.

    Time frame: Enrolment visit

  3. Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.

    Time frame: Enrolment visit

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: FEELING

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 10, 2011
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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