跳至主要内容
临床试验/NCT07469007
NCT07469007招募中不适用

Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Percentage change in AMH (anti-mullerian hormone) levels between day 0 and month 12.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

¨Patients requiring complete macroscopic excision surgery

Experimental

干预措施: pelvic ultrasound (Procedure)

¨Patients requiring complete macroscopic excision surgery

Experimental

干预措施: Anti-Müllerian hormone assay (Procedure)

¨Patients requiring complete macroscopic excision surgery

Experimental

干预措施: Questionnaire (Other)

Patients without surgical intervention

Placebo Comparator

干预措施: pelvic ultrasound (Procedure)

Patients without surgical intervention

Placebo Comparator

干预措施: Anti-Müllerian hormone assay (Procedure)

Patients without surgical intervention

Placebo Comparator

干预措施: Questionnaire (Other)

结局指标

主要结局

Percentage change in AMH (anti-mullerian hormone) levels between day 0 and month 12.

时间窗: from enrollment to the end of the participation at 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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