Clinical trial NCT01351051: A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis
Official title: A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-05-10
Enrollment: 1008
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.
timeFrame: Enrolment visit
Secondary outcomes:
measure: Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.
timeFrame: Enrolment visit
measure: Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.
timeFrame: Enrolment visit
measure: Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.
timeFrame: Enrolment visit
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Zhejiang
country: China
facility: Women's Hospital School of Medicine, Zhejiang University
city: Paris
country: France
facility: Hôpital St Vincent de Paul
city: Ivanovo
country: Russian Federation
facility: Research Institute of Maternity and Childhood named after V.N. Gorodkov
city: Moscow
country: Russian Federation
facility: Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Dai Y, Zhou Y, Zhang X, Xue M, Sun P, Leng J, Chapron C. Factors associated with deep infiltrating endometriosis versus ovarian endometrioma in China: a subgroup analysis from the FEELING study. BMC Womens Health. 2018 Dec 22;18(1):205. doi: 10.1186/s12905-018-0697-7.
citation: Chapron C, Lang JH, Leng JH, Zhou Y, Zhang X, Xue M, Popov A, Romanov V, Maisonobe P, Cabri P. Factors and Regional Differences Associated with Endometriosis: A Multi-Country, Case-Control Study. Adv Ther. 2016 Aug;33(8):1385-407. doi: 10.1007/s12325-016-0366-x. Epub 2016 Jun 24.