EndometriosisENDORONCT07469007
Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve (ENDORO)
A study testing pelvic ultrasound, Anti-Müllerian hormone assay and Questionnaire in people with Endometriosis and Ovarian Reserve, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Endometriosis is a chronic condition typically affecting women of reproductive age and often responsible for chronic pelvic pain and/or infertility. Its prevalence is estimated at 10% of the female population. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Endometriosis, Ovarian Reserve
- What is being tested?
- pelvic ultrasound, Anti-Müllerian hormone assay and Questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2025to 11 Feb 2028
- Phase
- Interventional
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, aged 18 to 39 years old;
- Suspected severe deep posterior pelvic endometriosis on reference pelvic MRI (ovarian kissing, obliteration of the pouch of Douglas) with concordant clinical examination, or confirmed severe deep posterior pelvic endometriosis during exploratory laparoscopy;
- Patient affiliated with or covered by a social security plan;
- Patient having been informed and having given her free, informed, and written consent
Who cannot join
- Presence of ovarian involvement defined by the presence of at least one endometrioma >5 mm;
- History of surgery for severe deep endometriosis;
- Severe preoperative premature ovarian insufficiency (defined by AMH <1ng/mL and antral follicle count <8);
- Concurrent use of GnRH agonist therapy at or within the preceding 3 months of enrollment;
- BMI >35 kg/m²;
- Menopausal status;
Show all 9Show fewer
- Patient participating in another trial with an exclusion period that has not yet expired at the time of screening;
- Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision;
- Pregnant, breastfeeding, or postpartum woman.
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
Clinique la croix du sud
Quint-Fonsegrives, 31130
Fabien Vidal, Dr, 0033609334578, drfabienvidal@gmail.com
About this study
Official title: Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve
Endometriosis is a chronic condition typically affecting women of reproductive age and often responsible for chronic pelvic pain and/or infertility.
Its prevalence is estimated at 10% of the female population. Deep endometriosis is a specific phenotype of the disease, defined histologically by infiltration of the peritoneum exceeding 5 mm or by fibromuscular plaques infiltrating the muscularis propria of the abdominopelvic organs. It affects approximately 12 to 20% of patients with endometriosis.
Read more
Surgery is one of the treatment options. Its aim is anatomical restoration, notably through complete macroscopic resection of the lesions and the release of adhesions, particularly those affecting the adnexa. While the negative impact of cystectomies on ovarian reserve is well known, the impact of surgery for severe deep endometriosis without ovarian involvement has never been studied. Yet, these procedures are regularly performed, and in the vast majority of cases on women of reproductive age. Moreover, the impression gathered in routine practice suggests a decrease in reserve parameters of around 5%. Therefore, understanding the actual impact of the procedure on ovarian reserve would, if it were concrete, allow for expanding the indications for preoperative fertility preservation to this subgroup of patients.
The main objective is to evaluate the impact of complete macroscopic resection of severe deep posterior pelvic endometriosis on the change in AMH levels at 12 months compared to an unexposed group.
- Conditions
- Endometriosis, Ovarian Reserve
- Being tested
- pelvic ultrasound, Anti-Müllerian hormone assay, Questionnaire
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic ultrasoundProcedure or surgery
Vaginal pelvic ultrasound. The examination is performed with an empty bladder using a 4-9 MHz vaginal probe positioned in a probe cover.
Anti-Müllerian hormone assayProcedure or surgery
A minimum of 0.5 ml of blood is collected using a 0.8 mm diameter (21 G) hollow needle and collected in a dry SST tube with serum separation.
QuestionnaireOther
Visual Analogue Scale questionnaire Questionnaire EHP-5 (Endometriosis Health Profile) Questionnaire FSFI (Female Sexual Function Index)
| Study group | Role | What they receive |
|---|---|---|
| ¨Patients requiring complete macroscopic excision surgery | Experimental | Not described Receives: Procedure: pelvic ultrasound; Procedure: Anti-Müllerian hormone assay; Other: Questionnaire |
| Patients without surgical intervention | Placebo comparator | Not described Receives: Procedure: pelvic ultrasound; Procedure: Anti-Müllerian hormone assay; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in AMH (anti-mullerian hormone) levels between day 0 and month 12.
Measured: from enrollment to the end of the participation at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start11 Feb 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion11 Feb 2028 (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 GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469007
- Sponsor's protocol ID
- 2023-A01489-36
- Acronym
- ENDORO
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve
- ClinicalTrials.gov ID
- NCT07469007
- Acronym / sponsor ID
- ENDORO / 2023-A01489-36
- Conditions
- Endometriosis, Ovarian Reserve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 11 Feb 2028 (estimated)
- First posted
- 13 Mar 2026 (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.
Endometriosis is a chronic condition typically affecting women of reproductive age and often responsible for chronic pelvic pain and/or infertility.
Its prevalence is estimated at 10% of the female population. Deep endometriosis is a specific phenotype of the disease, defined histologically by infiltration of the peritoneum exceeding 5 mm or by fibromuscular plaques infiltrating the muscularis propria of the abdominopelvic organs. It affects approximately 12 to 20% of patients with endometriosis.
Surgery is one of the treatment options. Its aim is anatomical restoration, notably through complete macroscopic resection of the lesions and the release of adhesions, particularly those affecting the adnexa. While the negative impact of cystectomies on ovarian reserve is well known, the impact of surgery for severe deep endometriosis without ovarian involvement has never been studied. Yet, these procedures are regularly performed, and in the vast majority of cases on women of reproductive age. Moreover, the impression gathered in routine practice suggests a decrease in reserve parameters of around 5%. Therefore, understanding the actual impact of the procedure on ovarian reserve would, if it were concrete, allow for expanding the indications for preoperative fertility preservation to this subgroup of patients.
The main objective is to evaluate the impact of complete macroscopic resection of severe deep posterior pelvic endometriosis on the change in AMH levels at 12 months compared to an unexposed group.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ¨Patients requiring complete macroscopic excision surgery | Experimental | Procedure: pelvic ultrasound, Procedure: Anti-Müllerian hormone assay, Other: Questionnaire |
| Patients without surgical intervention | Placebo comparator | Procedure: pelvic ultrasound, Procedure: Anti-Müllerian hormone assay, Other: Questionnaire |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, aged 18 to 39 years old;
- Suspected severe deep posterior pelvic endometriosis on reference pelvic MRI (ovarian kissing, obliteration of the pouch of Douglas) with concordant clinical examination, or confirmed severe deep posterior pelvic endometriosis during exploratory laparoscopy;
- Patient affiliated with or covered by a social security plan;
- Patient having been informed and having given her free, informed, and written consent
Key exclusion criteria (9 listed)
- Presence of ovarian involvement defined by the presence of at least one endometrioma >5 mm;
- History of surgery for severe deep endometriosis;
- Severe preoperative premature ovarian insufficiency (defined by AMH <1ng/mL and antral follicle count <8);
- Concurrent use of GnRH agonist therapy at or within the preceding 3 months of enrollment;
- BMI >35 kg/m²;
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 |
|---|---|---|
| pelvic ultrasoundVaginal pelvic ultrasound. The examination is performed with an empty bladder using a 4-9 MHz vaginal probe positioned in a probe cover. | Procedure or surgery | Patients without surgical intervention, ¨Patients requiring complete macroscopic excision surgery |
| Anti-Müllerian hormone assayA minimum of 0.5 ml of blood is collected using a 0.8 mm diameter (21 G) hollow needle and collected in a dry SST tube with serum separation. | Procedure or surgery | Patients without surgical intervention, ¨Patients requiring complete macroscopic excision surgery |
| QuestionnaireVisual Analogue Scale questionnaire Questionnaire EHP-5 (Endometriosis Health Profile) Questionnaire FSFI (Female Sexual Function Index) | Other | Patients without surgical intervention, ¨Patients requiring complete macroscopic excision surgery |
Primary outcome
Percentage change in AMH (anti-mullerian hormone) levels between day 0 and month 12.
Time frame: from enrollment to the end of the participation at 12 months
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 16 Jul 2026.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
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
Endometriosis Pelvic, Endometriosis Ovaries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic ultrasound, Anti-Müllerian hormone assay and Questionnaire in people with Endometriosis and Ovarian Reserve, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 9 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 16 Jul 2026. 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. Some participants in this study may receive a placebo. 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 Jean-François Oudet (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in AMH (anti-mullerian hormone) levels between day 0 and month 12. (time frame: from enrollment to the end of the participation at 12 months). 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 16 Jul 2026.