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

Completed

• Conditions: Endometriosis

• Registration Number: NCT01351051
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-08
• Study Start: 2011-05
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1008

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Women's Hospital School of Medicine, Zhejiang University; 🇨🇳 Zhejiang, China

Research Institute of Maternity and Childhood named after V.N. Gorodkov; 🇷🇺 Ivanovo, Russian Federation

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology; 🇷🇺 Moscow, Russian Federation

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Hôpital St Vincent de Paul; 🇫🇷 Paris, France

Peking University First Hospital; 🇨🇳 Beijing, China