NCT01351051

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2011

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

April 8, 2011

Last Update Submit

January 11, 2019

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

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

    Enrolment visit

Secondary Outcomes (3)

  • 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

Study Arms (4)

No endometriosis

Superficial endometriosis

Endometrioma

Deep infiltrating endometriosis

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Peking Union Medical College Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

The Third Xiangya Hospital of Central South University

Changsha, China

Location

Women's Hospital School of Medicine, Zhejiang University

Zhejiang, China

Location

Hôpital St Vincent de Paul

Paris, France

Location

Research Institute of Maternity and Childhood named after V.N. Gorodkov

Ivanovo, Russia

Location

Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology

Moscow, Russia

Location

Related Publications (2)

  • 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.

    PMID: 30577792DERIVED

  • 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.

    PMID: 27342743DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2011

First Posted

May 10, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

FR(1)RU(2)CN(4)