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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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