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

NCT07469007 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-13

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Ramsay Générale de Santé

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2028-01-01
Completion
2028-02-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07469007 on ClinicalTrials.gov