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

Ramsay Générale de Santé

Status: Enrolling

Conditions: Endometriosis; Ovarian Reserve

Treatments: Other: Questionnaire; Procedure: pelvic ultrasound; Procedure: Anti-Müllerian hormone assay

Study type: Interventional

Funder types: Other

Identifiers

NCT07469007

2023-A01489-36

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

¨Patients requiring complete macroscopic excision surgery

Experimental group

Treatment:

Procedure: Anti-Müllerian hormone assay

Procedure: pelvic ultrasound

Other: Questionnaire

Patients without surgical intervention

Placebo Comparator group

Treatment:

Procedure: Anti-Müllerian hormone assay

Procedure: pelvic ultrasound

Other: Questionnaire