Endometriosis, Ovarian Reserve
Conditions
Brief 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.
Interventions
PROCEDUREpelvic ultrasound
Vaginal pelvic ultrasound. The examination is performed with an empty bladder using a 4-9 MHz vaginal probe positioned in a probe cover.
PROCEDUREAnti-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.
OTHERQuestionnaire
Visual Analogue Scale questionnaire Questionnaire EHP-5 (Endometriosis Health Profile) Questionnaire FSFI (Female Sexual Function Index)
Sponsors
Ramsay Générale de Santé
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Contacts
CONTACTJean-François Oudet
Outcome results
None listed