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

NCT07469007 | Recruiting

• 1 other identifier: 2023-A01489-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometriosis; Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

¨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

Interventions

pelvic ultrasound PROCEDURE

Vaginal pelvic ultrasound. The examination is performed with an empty bladder using a 4-9 MHz vaginal probe positioned in a probe cover.

Patients without surgical intervention; ¨Patients requiring complete macroscopic excision surgery

Anti-Müllerian hormone assay PROCEDURE

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.

Patients without surgical intervention; ¨Patients requiring complete macroscopic excision surgery

Questionnaire OTHER

Visual Analogue Scale questionnaire Questionnaire EHP-5 (Endometriosis Health Profile) Questionnaire FSFI (Female Sexual Function Index)

Patients without surgical intervention; ¨Patients requiring complete macroscopic excision surgery

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision;
• Pregnant, breastfeeding, or postpartum woman.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique la croix du sud

Quint-Fonsegrives, 31130, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jean-François Oudet

CONTACT

0033683346567; jf.oudet@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: February 11, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 11, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

FR (1)