EndometriosisENDOCHAPNCT04481321
Clinical and Molecular Study of Endometriosis and Adenomyosis
An observational study of Endometriosis and Adenomyosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Endometriosis, Adenomyosis
- What is being tested?
- Biological/Vaccine
- Type of treatment
- Vaccines
- How many people
- 5,300 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Dec 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- HIV-positive women, HBV and HCV
- During pregnancy
- Having a cancer diagnosis
- Refusing to sign a consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Port Royal, hospital cochin
Paris, 75014
Louis Marcellin, MD, PhD, 1 58415495 ext. +33, louis.marcellin@aphp.fr
About this study
Official title: ENDOCHAP Monocentric Cohort: 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.
Read the detailed description
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.
- Conditions
- Endometriosis, Adenomyosis
- Being tested
- Biological/Vaccine
- Keywords
- Endometriosis, Adenomyosis, pain, infertility, disease progressiveness
- Medical subject headings
- Endometriosis, Adenomyosis, Pain, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/VaccineBiological
Also called Peripheral blood,, Vaginal and urinary swab, Endometriosis lesions,endometrial biopsies, Myometer biopsies
| Study group | Role | What they receive |
|---|---|---|
| Patient with benign gynaecologic disease | Patients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass, Receives: Biological: Biological/Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Composite outcome
Measured: 10 years
Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient
Measured: 10 years
Secondary outcomes (17)
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Measured: 1 year
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Measured: 3 years
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Measured: 5 years
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Measured: 7 years
Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI
Measured: 10 years
meeting specific criteria for endometriosis and adenomyosis lesions
Measured: 10 years
Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.
Measured: 10 years
Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.
Measured: 10 years
Association between clinical data and the occurrence of the disease
Measured: 10 years
Creating a score on clinical diagnosis
Measured: 10 years
- Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate
Measured: 10 years
Serum dosage of circulating antibodies before and after surgical treatment of lesions
Measured: 10 years
Metabolic pathway exploration in adenomyosis lesions
Measured: 10 years
Study of the presence of autoantibodies in cases of endometriosis and adenomyosis
Measured: 10 years
Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)
Measured: 10 years
To study the natural history of deep endometriosis lesions and analysis of focused invasion processes, epithelio-mesenchymatous transitions, and fibrogenesis using molecular biology techniques
Measured: 10 years
Characterization of the microbiota in urine and vaginal samples.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study startMay 2006
- Primary completionJun 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Louis Marcellin, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481321
- Sponsor's protocol ID
- NI18108
- Acronym
- ENDOCHAP
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis
- ClinicalTrials.gov ID
- NCT04481321
- Acronym / sponsor ID
- ENDOCHAP / NI18108
- Conditions
- Endometriosis, Adenomyosis
- Keywords
- Endometriosis, Adenomyosis, pain, infertility, disease progressiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- May 2006 (actual)
- Primary completion
- Jun 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with benign gynaecologic disease | – | Biological: Biological/VaccinePatients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass, |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- HIV-positive women, HBV and HCV
- During pregnancy
- Having a cancer diagnosis
- Refusing to sign a consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological/VaccineAlso: Peripheral blood,, Vaginal and urinary swab, Endometriosis lesions,endometrial biopsies, Myometer biopsies | Biological | Patient with benign gynaecologic disease |
Primary outcome
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
Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient
Time frame: 10 years
17 secondary outcomes
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Time frame: 1 year
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Time frame: 3 years
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Time frame: 5 years
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Time frame: 7 years
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
meeting specific criteria for endometriosis and adenomyosis lesions
Time frame: 10 years
Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.
Time frame: 10 years
Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.
Time frame: 10 years
Association between clinical data and the occurrence of the disease
Time frame: 10 years
Creating a score on clinical diagnosis
Time frame: 10 years
- 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
Serum dosage of circulating antibodies before and after surgical treatment of lesions
Time frame: 10 years
Metabolic pathway exploration in adenomyosis lesions
Time frame: 10 years
Study of the presence of autoantibodies in cases of endometriosis and adenomyosis
Time frame: 10 years
Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)
Time frame: 10 years
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
Characterization of the microbiota in urine and vaginal samples.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
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Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
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Endometriosis Transcriptomic Cell Atlas
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Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
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Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis Marcellin, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Adenomyosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Chapron, MD (1 58 41 19 33 ext. +33, charles.chapron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.