Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve (ENDORO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pelvic ultrasound, Anti-Müllerian hormone assay, Questionnaire.
- Who it may be relevant to
- Registry conditions: Endometriosis, Ovarian Reserve. Basic parameters: 18 years — 39 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve
Overview
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.
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)
Primary outcome measures
- 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 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Clinique la croix du sud — Quint-Fonsegrives
Identifiers
NCT: NCT07469007 · 2023-A01489-36