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

RecruitingNAAges 18 Years - 39 YearsFemaleGCS Ramsay Santé pour l'Enseignement et la Recher…
NCT07469007 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, th

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📋 Eligibility rules (as published)
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.
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What it tests

  • pelvic ultrasound
  • Anti-Müllerian hormone assay
  • Questionnaire
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Where

1 site
Clinique la croix du sud
Quint-Fonsegrives, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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