Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve (ENDORO) (ENDORO)

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.

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 Overview

• Status: Recruiting
• Conditions: Endometriosis; Ovarian Reserve
• Intervention / Treatment: Procedure: pelvic ultrasound; Procedure: Anti-Müllerian hormone assay; Other: Questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-François Oudet; Phone Number: 0033683346567; Email: jf.oudet@ecten.eu

Study Locations

• France
  • Quint-Fonsegrives, France, 31130
    • Recruiting
    • Clinique La Croix Du Sud
    • Contact: Fabien Vidal, Dr; Phone Number: 0033609334578; Email: drfabienvidal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ¨Patients requiring complete macroscopic excision surgery	Procedure: pelvic ultrasound; Vaginal pelvic ultrasound. The examination is performed with an empty bladder using a 4-9 MHz vaginal probe positioned in a probe cover.; Procedure: Anti-Müllerian hormone assay; 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.; Other: Questionnaire; Visual Analogue Scale questionnaire Questionnaire EHP-5 (Endometriosis Health Profile) Questionnaire FSFI (Female Sexual Function Index)
Placebo Comparator: Patients without surgical intervention	Procedure: pelvic ultrasound; Vaginal pelvic ultrasound. The examination is performed with an empty bladder using a 4-9 MHz vaginal probe positioned in a probe cover.; Procedure: Anti-Müllerian hormone assay; 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.; Other: Questionnaire; Visual Analogue Scale questionnaire Questionnaire EHP-5 (Endometriosis Health Profile) Questionnaire FSFI (Female Sexual Function Index)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in AMH (anti-mullerian hormone) levels between day 0 and month 12.	from enrollment to the end of the participation at 12 months

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 11, 2028

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 2023-A01489-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No