Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve (ENDORO)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
pelvic ultrasound
Procedure/SurgeryVaginal 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
Procedure/SurgeryA 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
Other interventionVisual Analogue Scale questionnaire Questionnaire EHP-5 (Endometriosis Health Profile) Questionnaire FSFI (Female Sexual Function Index)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ¨Patients requiring complete macroscopic excision surgeryExperimental treatment 3 interventions
Group B: Patients without surgical interventionPlacebo comparator 3 interventions
Trial outcomes
Primary outcomes
1
Percentage change in AMH (anti-mullerian hormone) levels between day 0 and month 12.
Time frame
from enrollment to the end of the participation at 12 monthsSponsors and contacts
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Source ClinicalTrials.gov