Ongoing Clinical Studies
The EndoBiota project aims to explore the role of the gut and genital microbiota in the pathophysiology of endometriosis.
Endometriosis is a chronic inflammatory disease affecting approximately 10% of women of reproductive age and is characterized by the presence of endometrial-like tissue outside the uterine cavity, leading in particular to pelvic pain and infertility.
Recent studies suggest that endometriosis may be associated with alterations in the microbiota (dysbiosis). Interactions between the microbiota, the immune system, and inflammation may contribute to the initiation and progression of the disease.
The EndoBiota project therefore aims to characterize microbiota profiles associated with endometriosis and to better understand their role in the pathophysiological mechanisms of the disease.
Project Objectives
Primary objective
Identify alterations in the gut and genital microbiota associated with endometriosis.
Secondary objectives
- Study the association between microbiota composition and endometriosis severity
- Identify microbiota signatures specific to the disease
- Explore interactions between the microbiota, inflammation, and the immune system
- Identify potential microbiota-related therapeutic targets
Methodology
EndoBiota is based on a translational approach combining clinical data and microbiological analyses.
Analyses include in particular:
- Characterization of the gut and genital microbiota
- Bacterial sequencing, including 16S rRNA sequencing
- Metagenomic analyses
- Correlation with patients’ clinical and phenotypic data
This approach makes it possible to identify microbiota profiles associated with the presence and severity of endometriosis.
Study Population
The study includes patients with endometriosis and control women without endometriosis.
Participants are recruited in an expert endometriosis center.
Investigating Center
The study is conducted at the expert endometriosis center of: Cochin–Port-Royal Hospital, AP-HP – Université Paris Cité
Project Summary
| Item | Description |
| Project name | EndoBiota |
| Principal investigator | Dr Guillaume Parpex |
| Scientific team | Charles Chapron, Louis Marcellin |
| Coordinating institution | Université Paris Cité – Institut Cochin |
| Study type | Translational observational study |
| Design | Case-control study |
| Center | Single-center |
| Population | Women with endometriosis and controls |
| Project duration | Prospective study |
| Funding | ENDOFRANCE and the Urogenital Microbiota Academy |
Keywords
Endometriosis — microbiota — gut microbiota — genital microbiota — inflammation — dysbiosis
The ENDOFAT project aims to better understand the role of adipose tissue in the pathophysiology of endometriosis.
Endometriosis is a chronic inflammatory disease characterized by the presence of endometrial-like tissue outside the uterine cavity. It is associated with chronic pelvic pain, digestive or urinary symptoms, and may lead to infertility.
Recent data suggest that adipose tissue may play an important role in the systemic and local inflammation associated with endometriosis. In particular, adipocytes and immune cells present in adipose tissue may contribute to the production of inflammatory mediators and influence the development and progression of endometriotic lesions.
The ENDOFAT project therefore aims to explore the interactions between adipose tissue, inflammation, and endometriosis in order to better understand the biological mechanisms involved in the disease.
Project Objectives
Primary objective
Study the biological and inflammatory characteristics of adipose tissue in patients with endometriosis.
Secondary objectives
- Analyze the role of adipose tissue in inflammatory mechanisms associated with endometriosis
- Characterize interactions between adipose tissue, immune cells, and endometriotic lesions
- Identify biological signatures associated with disease severity
- Explore new therapeutic avenues targeting metabolic and inflammatory mechanisms
Methodology
ENDOFAT is a translational study based on the analysis of biological samples collected from patients with endometriosis during surgical management.
Analyses include in particular:
- Study of adipose tissue collected during surgery
- Histological and immunological analyses
- Molecular analyses of inflammatory mediators
- Correlation of biological data with patients’ clinical characteristics
This approach makes it possible to explore the potential role of adipose tissue in inflammatory mechanisms involved in endometriosis.
Study Population
The study includes patients managed for endometriosis in an expert center. Participants are recruited during their surgical management.
Inclusion Criteria
- Adult women
- Confirmed or suspected diagnosis of endometriosis
- Indication for endometriosis surgery
- Management in an expert endometriosis center
- Written informed consent for participation and collection of biological samples
Investigating Center
The study is conducted at the expert endometriosis center of:
Georges Pompidou Hospital, AP-HP – Université Paris Cité
Project Summary
| Item | Description |
| Project name | ENDOFAT |
| Principal investigator | Dr Meriem KOUAL |
| Coordinating institution | Université Paris Cité |
| Study type | Translational observational study |
| Design | Prospective study |
| Center | Single-center |
| Population | Surgically treated patients with endometriosis |
| Samples studied | Adipose tissue |
| Project duration | Prospective study |
| Funding | ANR jeune chercheur |
Keywords
Endometriosis — adipose tissue — inflammation — immunology — pathophysiology
The ENDOTENS project aims to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) in the management of chronic pelvic pain related to endometriosis.
Chronic pelvic pain is one of the most frequent and disabling symptoms of endometriosis. It may persist despite hormonal or surgical treatments and relies on complex mechanisms involving nociceptive, neuropathic, and nociplastic components.
In this context, non-pharmacological approaches represent an important avenue for improving pain management and reducing reliance on medication. Transcutaneous neurostimulation (TENS) is a non-invasive technique already used in the management of several chronic pain conditions.
The ENDOTENS study evaluates the efficacy of a connected neurostimulation device, actiTENS, developed to relieve pain. This device delivers transcutaneous electrical stimulation controlled via a mobile application, allowing patients to adjust the duration and intensity of stimulation.
The objective of the study is to determine whether regular use of this device can significantly reduce pain intensity in patients with endometriosis and improve their quality of life.
Project Objectives
Primary objective
Demonstrate the analgesic effect of actiTENS transcutaneous nerve stimulation treatment over a three-month period in patients with chronic pelvic pain related to endometriosis, compared with low-intensity stimulation used as a control.
Secondary objectives
- Evaluate the impact of treatment on patients’ quality of life
- Analyze the effect of the device on function and pain-related limitations
- Characterize patient profiles associated with treatment response
- Determine the optimal conditions of device use in clinical practice
- Assess device tolerability and safety
- Analyze the impact of device use on healthcare utilization and analgesic consumption
Methodology
ENDOTENS is a prospective, randomized, multicenter, controlled clinical trial using a cross-over design.
In the first phase of the study, participants are randomized between two treatment sequences:
- Active treatment with actiTENS transcutaneous nerve stimulation
- Control treatment based on low-intensity stimulation
Each treatment period lasts three months and is separated by a 28-day washout period.
In a second phase, all patients receive open-label actiTENS treatment for an additional three months in order to evaluate use of the device under real-life conditions.
The device is applied to the anterior pelvic and lumbosacral regions, with stimulation sessions of at least 60 minutes twice daily.
Study Population
The study includes adult women with confirmed endometriosis and chronic pelvic pain associated with the disease.
Participants are followed in centers specialized in the management of endometriosis or pain treatment centers in France.
Inclusion Criteria
- Women aged over 18 years
- Endometriosis diagnosis confirmed by imaging (MRI or ultrasound)
- Chronic pelvic pain related to endometriosis for at least three months
- Pelvic pain present at least 15 days per month
- Mean pain intensity ≥ 4 on a numerical rating scale from 0 to 10
- Stable hormonal and analgesic treatment for at least three months
- Ability to use the device and the associated mobile application
- Signed informed consent
Investigating Center
The study is coordinated by the pain center of: Cochin Hospital, AP-HP – Université Paris Cité
It also involves several centers specialized in the management of endometriosis and pain in France.
Project Summary
| Item | Description |
| Project name | ENDOTENS |
| Coordinating investigator | S. Perrot |
| Scientific director | L. Marcellin |
| Coordinating institution | AP-HP / Université Paris Cité |
| Sponsor | AP-HP – DRCI |
| Study type | Medical device clinical trial |
| Design | Prospective randomized multicenter cross-over study with open-label extension |
| Centers | 29 centers in France |
| Population | Women with endometriosis and chronic pelvic pain |
| Intervention studied | actiTENS transcutaneous nerve stimulation |
| Device | actiTENS – connected neurostimulation device |
| Study size | participants |
| Inclusion period | 18 months |
| Participation duration per patient | 11 months |
| Funding | Clinical Hospital Research Program (PHRC 2024) |
The EPIVO project studies the epigenetic effects of in vitro fertilization (IVF) and endometriosis on human embryos at the preimplantation stage.
Assisted reproductive technologies, particularly IVF, modify the environment in which the embryo develops during the earliest stages of development. Several studies suggest that these conditions may influence gene expression through epigenetic mechanisms, that is, changes in gene expression without modification of the DNA sequence.
In addition, endometriosis is frequently associated with infertility and may also influence embryo quality or implantation mechanisms. Some studies suggest in particular that the disease may affect implantation rates during IVF cycles.
The EPIVO study therefore aims to analyze epigenetic modifications observed in embryos obtained through IVF and to determine whether endometriosis may modulate these mechanisms.
Project Objectives
Primary objective
Study the impact of IVF and endometriosis on epigenetic modifications observed in human embryos at the preimplantation stage.
Secondary objectives
- Analyze the epigenetic profiles of embryos obtained through IVF
- Compare these profiles according to the presence or absence of endometriosis in patients
- Improve understanding of the molecular mechanisms involved in early embryonic development
- Explore the potential impact of these mechanisms on implantation success
Methodology
EPIVO is based on the analysis of human embryos at the preimplantation stage obtained during IVF cycles.
Analyses include in particular:
- Epigenetic analyses of embryos
- Study of DNA methylation changes
- Gene expression analyses
- Comparison between embryos from patients with or without endometriosis
These analyses make it possible to explore the molecular mechanisms involved in early embryonic development and the potential impact of conception conditions on the epigenome.
Study Population
The study includes human embryos obtained through IVF cycles.
Analyses focus in particular on preimplantation embryos from patients managed for infertility, with or without endometriosis.
Inclusion Criteria
- Patients undergoing IVF
- Human preimplantation embryos available for research
- Patient consent for the use of embryos for research purposes
- Management in an assisted reproduction center
Investigating Center
The study is conducted at the assisted reproduction center of:
Cochin–Port-Royal Hospital, AP-HP – Université Paris Cité
Project Summary
| Item | Description |
| Project name | EPIVO |
| Principal investigators | Dr C. Patrat, Dr D. Vaiman |
| Coordinating institution | Université Paris Cité |
| Study type | Translational study |
| Design | Experimental study on preimplantation embryos |
| Center | Single-center |
| Population | Embryos obtained from IVF cycles |
| Project duration | 2024 – 2029 |
| Funding | Fondation LVMH |
Keywords
Endometriosis — IVF — epigenetics — preimplantation embryo — embryonic development
The GYNAB project aims to evaluate the value of digitalized post-emergency gynecological follow-up based on the use of a connected health application.
Visits to gynecological emergency departments are a frequent reason for hospital attendance. In certain clinical situations, patients need to be reassessed in the days following their emergency visit in order to evaluate disease progression, review additional test results, or adapt management. This follow-up is usually based on a scheduled in-person consultation.
With the development of digital health technologies, new solutions now make it possible to digitalize certain stages of the care pathway through secure platforms enabling the transmission of clinical and biological information between patients and medical teams.
The GYNAB study aims to evaluate a model of post-emergency digital follow-up using an application that allows patients to transmit clinical data and examination results, while enabling physicians to monitor clinical progression remotely and adapt management when necessary.
By comparing this approach with conventional in-person follow-up, the study aims to determine whether digitalization of post-emergency follow-up can improve patients’ experience, optimize care organization, and reduce unscheduled consultations.
Project Objectives
Primary objective
Compare overall patient satisfaction between home-based digital post-emergency follow-up via a connected health application and conventional in-person post-emergency follow-up at the hospital.
Secondary objectives
- Evaluate overall patient satisfaction at 28 days
- Analyze PROM-ED scores across four dimensions: symptom relief, understanding of management, reassurance, and care planning
- Evaluate hospitalization rates during follow-up
- Evaluate rates of unscheduled emergency consultations
- Evaluate rates of surgical intervention during follow-up
- Measure cumulative patient time spent in hospital
- Evaluate satisfaction among physicians involved in care
Methodology
GYNAB is a randomized comparative clinical trial designed to compare two modalities of post-emergency gynecological follow-up.
Patients for whom post-emergency follow-up is indicated are randomized into two groups:
- One group receiving digital follow-up via a connected health application
- One group receiving conventional post-emergency follow-up with a scheduled in-person consultation
In the digital group, patients regularly enter clinical data via the application (pain, temperature, bleeding, symptoms, etc.) and transmit the results of prescribed tests. Physicians can monitor these data remotely, adapt management instructions, and contact patients when necessary.
Satisfaction data and clinical outcomes are collected at several time points during follow-up, particularly at 7 days and 28 days.
Study Population
The study includes women attending gynecological emergency departments for whom post-emergency follow-up is indicated.
The clinical situations concerned include in particular:
- Genital infection
- Uncomplicated ectopic pregnancy
- Pregnancy of unknown location
- Medically managed miscarriage
- First-trimester bleeding
- Hyperemesis gravidarum
Inclusion Criteria
- Women aged 18 to 60 years
- First consultation in gynecological emergency care for the episode under study
- Medical indication for post-emergency follow-up
- Stable clinical condition allowing discharge home
- Ability to use the follow-up application
- Signed informed consent
Investigating Center
The study is conducted within the Department of Gynecology-Obstetrics II and Reproductive Medicine at: Cochin–Port-Royal Hospital, AP-HP – Université Paris Cité
Project Summary
| Item | Description |
| Project name | GYNAB |
| Coordinating investigator | L. Campin |
| Scientific lead | L. Marcellin |
| Coordinating institution | AP-HP / Université Paris Cité |
| Sponsor | AP-HP – DRCI |
| Study type | Comparative clinical trial |
| Design | Prospective randomized study |
| Center | Single-center |
| Population | Women attending gynecological emergency care requiring post-emergency follow-up |
| Intervention studied | Digital follow-up via a connected health application |
| Comparator | Conventional in-person post-emergency follow-up |
| Study size | 200 patients |
| Inclusion period | 24 months |
| Follow-up duration | 28 days |
| Funding | NABLA (40 %) – BPI France (60 %) |
Keywords
Endometriosis — gynecological emergencies — telemonitoring — digital health — medical application — care pathway — PROM
The MultiMENDo project aims to identify new diagnostic and prognostic biomarkers for endometriosis through the analysis of menstrual blood.
Endometriosis is a chronic inflammatory disease affecting approximately 10% of women of reproductive age and remains associated with a substantial diagnostic delay, which may extend over several years. To date, no reliable non-invasive biomarker is available for early diagnosis and better patient stratification.
Menstrual blood is a particularly relevant biological source for studying the disease, as it contains both endometrial cells and immune cells involved in the pathophysiology of endometriosis.
Using a multi-omics approach, the MultiMENDo project aims to improve understanding of the molecular mechanisms of the disease and to identify non-invasive biological markers that may optimize diagnosis and patient management.
Project Objectives
Primary objective
Identify molecular biomarkers of endometriosis in menstrual blood capable of distinguishing patients with endometriosis from control women.
Secondary objectives
- Identify prognostic biomarkers associated with disease severity
- Identify predictive biomarkers of treatment response
- Study interactions between endometrial cells and immune cells involved in the pathophysiology of endometriosis
- Develop experimental endometrial organoid models to explore new therapeutic strategies
Methodology
MultiMENDo is a single-center translational observational study based on the analysis of menstrual blood samples collected from participants.
Biological analyses rely on multi-omics approaches, including:
- Single-cell RNA sequencing
- Multiplex protein analyses
- Development of endometrial organoids
These approaches make it possible to explore the molecular mechanisms of the disease and identify biological signatures specific to endometriosis.
Study Population
The study plans to include approximately 250 participants: around 200 women with endometriosis and 50 control women without endometriosis.
Main Inclusion Criteria
- Women of reproductive age
- Active menstrual cycles
- Confirmed diagnosis of endometriosis (for the case group)
- Consent to participate in the study and provide biological samples
Project Summary
| Item | Description |
| Project name | MultiMENDo |
| Principal investigator | Pr Louis Marcellin |
| Scientific coordinator | Dr Ludivine Doridot |
| Study type | Translational observational study |
| Design | Case-control study |
| Center | Single-center |
| Population | ≈ 250 participants |
| Project duration | 2023 – 2028 |
| Funding | European Research Council – Horizon Europe (ERC Starting Grant) |
Keywords
Endometriosis — biomarkers — menstrual blood — multi-omics — non-invasive diagnosis — personalized medicine
The TENDANSE project aims to investigate neurological involvement associated with deep pelvic endometriosis using advanced magnetic resonance imaging techniques.
Pelvic endometriosis may cause severe chronic pain, particularly when lesions are located close to pelvic nerve structures. However, involvement of the pelvic nerves remains difficult to characterize using conventional imaging techniques.
The TENDANSE study uses an advanced MRI technique called Diffusion Tensor Imaging (DTI), which enables visualization of the microarchitecture of nerve fibers and the assessment of alterations in nerve structures. These approaches make it possible, in particular, to analyze abnormalities of the peripheral nervous system associated with endometriosis.
By correlating nerve abnormalities observed on imaging with patients’ symptoms, the study aims to improve understanding of pain mechanisms and optimize surgical planning.
Project Objectives
Primary objective
Study abnormalities of pelvic nerve structures in patients with endometriosis using MRI with Diffusion Tensor Imaging (DTI).
Secondary objectives
- Correlate nerve abnormalities observed on MRI with patients’ pain symptoms
- Improve characterization of neurological involvement in pelvic endometriosis
- Optimize surgical planning for endometriosis lesions involving nerve structures
- Contribute to improved functional outcomes and patient management
Methodology
TENDANSE is based on the use of advanced MRI to analyze pelvic nerve structures.
Analyses include in particular:
- Acquisition of pelvic MRI with Diffusion Tensor Imaging (DTI)
- Reconstruction and analysis of pelvic nerve fibers
- Identification of abnormalities in nerve structures
- Correlation of imaging data with clinical symptoms and surgical findings
This approach allows better characterization of neurological involvement associated with endometriosis and helps guide surgical strategy.
Study Population
The study includes patients with pelvic endometriosis managed in an expert center.
Participants undergo advanced MRI as part of the evaluation of their disease.
Inclusion Criteria
- Adult women
- Confirmed or suspected diagnosis of pelvic endometriosis
- Indication for pelvic MRI in the management of endometriosis
- Management in an expert endometriosis center
- Consent to participate in the study
Investigating Center
The study is conducted at the expert endometriosis center of: Cochin–Port-Royal Hospital, AP-HP – Université Paris Cité
Project Summary
| Item | Description |
| Project name | TENDANSE |
| Principal investigators | L. Fournier, A. Bellucci, L. Marcellin, S. Sarnacki |
| Coordinating institution | Université Paris Cité |
| Study type | Observational imaging study |
| Design | Prospective study |
| Center | Single-center |
| Population | Patients with pelvic endometriosis |
| Technique studied | MRI with Diffusion Tensor Imaging (DTI) |
| Clinical objective | Analysis of nerve involvement associated with endometriosis |
| Project duration | 2024 – 2029 |
| Funding | Fondation Paris Cité Université – “Saving Lives” programme |
Keywords
Endometriosis — MRI — Diffusion Tensor Imaging — pelvic nerves — pelvic pain — surgical planning