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

NCT ID: NCT01351051

Last Updated: 2019-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1008 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No endometriosis

No interventions assigned to this group

Superficial endometriosis

No interventions assigned to this group

Endometrioma

No interventions assigned to this group

Deep infiltrating endometriosis

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking Union Medical College Hospital

Beijing, , China

Site Status

Peking University First Hospital

Beijing, , China

Site Status

The Third Xiangya Hospital of Central South University

Changsha, , China

Site Status

Women's Hospital School of Medicine, Zhejiang University

Zhejiang, , China

Site Status

Hôpital St Vincent de Paul

Paris, , France

Site Status

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

Ivanovo, , Russia

Site Status

Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China France Russia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30577792 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27342743 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A-38-52014-185

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PET/MRI for Evaluation of Endometriosis
NCT06377553 ENROLLING_BY_INVITATION
Diagnostic Value of ICG in Endometriosis
NCT03850158 COMPLETED EARLY_PHASE1