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NCT Number: NCT04481321

Clinical and Molecular Study of Endometriosis and Adenomyosis

The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Port Royal, hospital cochin

Paris, 75014, France

Location status: Recruiting

Location contact

Louis Marcellin, MD, PhD

CONTACT

[email protected]

1 58415495 ext. +33

About this study

Endometriosis and adenomyosis are benign gynecological conditions which affect more than 10% of women, that typically cause pain and / or infertility, thereby exerting a negative impact on the patients' quality of life.

Although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases are defined by the presence of endometrial tissue outside the uterine cavity. Endometriosis is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis (SUP), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE) The most widely accepted pathophysiological hypothesis for endometriosis is that of the implantation of ectopic endometrial cells following peritoneal reflux. Endometriosis can be associated with adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into the myometrium, presenting different forms: diffuse, focal or cystic.

Due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult and affected patients are subject to a long delay for appropriate management.

We hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions and recurrences. Furthermore, highlighting specific clinical and molecular markers would shorten the diagnostic time.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women of age between - 18 and 42 years old.
  • In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.
  • Having a radiological diagnosis made by a referral practitioner and/or operated in the department

Exclusion criteria

  • HIV-positive women, HBV and HCV
  • During pregnancy
  • Having a cancer diagnosis
  • Refusing to sign a consent.

Treatment and study plan

Biological/Vaccine

Biological

Other names: Peripheral blood,, Vaginal and urinary swab, Endometriosis lesions,endometrial biopsies, Myometer biopsies, Peritoneal fluid, Follicular fluid biopsies

Primary outcomes

  1. Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

    Time frame: 10 years

    Composite outcome

  2. Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient

    Time frame: 10 years

Secondary outcomes

  1. Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

    Time frame: 1 year

  2. Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

    Time frame: 3 years

  3. Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

    Time frame: 5 years

  4. Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

    Time frame: 7 years

  5. Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI

    Time frame: 10 years

  6. meeting specific criteria for endometriosis and adenomyosis lesions

    Time frame: 10 years

  7. Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.

    Time frame: 10 years

  8. Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.

    Time frame: 10 years

  9. Association between clinical data and the occurrence of the disease

    Time frame: 10 years

  10. Creating a score on clinical diagnosis

    Time frame: 10 years

  11. - Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate

    Time frame: 10 years

  12. Serum dosage of circulating antibodies before and after surgical treatment of lesions

    Time frame: 10 years

  13. Metabolic pathway exploration in adenomyosis lesions

    Time frame: 10 years

  14. Study of the presence of autoantibodies in cases of endometriosis and adenomyosis

    Time frame: 10 years

  15. Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)

    Time frame: 10 years

  16. To study the natural history of deep endometriosis lesions and analysis of focused invasion processes, epithelio-mesenchymatous transitions, and fibrogenesis using molecular biology techniques

    Time frame: 10 years

  17. Characterization of the microbiota in urine and vaginal samples.

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Chapron, MD

CONTACT

[email protected]

1 58 41 19 33 ext. +33

Laurence Lecomte, PhD

CONTACT

[email protected]

1 58 41 34 78 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis

Acronym: ENDOCHAP

Important dates

Study start
2006
Primary completion
2040
Study completion
2040
First posted
Jul 22, 2020
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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