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CompletedNCT01351051FEELINGUpdated Jan 14, 2019

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

An observational study in Endometriosis, sponsored by Ipsen. Completed at 7 sites in 3 countries. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by Ipsen · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,008
Ages
18 Years to 41 Years
Sex
Female
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Study 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.

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Conditions studied

  • Endometriosis

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 1,008 is above the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 41 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,008 participants (actual)

Groups and cohorts

  • No endometriosis
  • Superficial endometriosis
  • Endometrioma
  • Deep infiltrating endometriosis
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What researchers measure

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

07

Study locations

7 sites
  • Peking Union Medical College Hospital
    Beijing, China
  • Peking University First Hospital
    Beijing, China
  • The Third Xiangya Hospital of Central South University
    Changsha, China
  • Women's Hospital School of Medicine, Zhejiang University
    Zhejiang, China
  • Hôpital St Vincent de Paul
    Paris, France
  • Research Institute of Maternity and Childhood named after V.N. Gorodkov
    Ivanovo, Russian Federation
  • Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology
    Moscow, Russian Federation
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References and documents

Publications

  • 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. PubMed 30577792 ↗
  • 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. PubMed 27342743 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01351051
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
May 10, 2011
Start date
May 2011
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Jan 14, 2019

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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