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

Study acronym: ENDORO
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Sponsor changed: Ramsay Générale de Santé to GCS Ramsay Santé pour l'Enseignement et la Recherche
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07469007
Lead Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions
(from sponsor)
Endometriosis, Ovarian Reserve
Related terms Endometriosis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov