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临床试验/NCT02400684
NCT02400684已完成不适用

ENDmetriosis and Reserve Ovarienne

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
118
试验地点
2
主要终点
Change from baseline in ovarian reserve (determined by AMH) at one year

研究概览

简要总结

Endometriosis is the ectopic implantation of endometrial glands and stroma, and can be ovarian and peritoneal (superficial or deep). There are 4 stages in endometriosis according to severity, and the stage is established on the basis of intra-operative observations. The AFSr classification is currently most used (I-IV,minimal, mild, moderate, severe). Most associated with endometriosis are subfertility and pelvic pain.

In the surgical management of deep endometriosis, the issue of fertility is pivotal. There is a higher rate of infertility in a population of women with endometriosis as compared to the general population, even though the mechanisms are not yet elucidated. Patients with deep endometriosis can be referred to the surgeon for subfertility, but even when they are referred for chronic pain, future fertility considerations are taken into account in the planning of the surgery, as the patients are often young.

It is now well documented that ovarian cystectomy is deleterious with regards to the ovarian reserve, and more so in endometriomas than in any other type of benign cysts. The ovarian reserve is the functional potential of the ovaries, reflecting the quantity and quality of remaining follicles. Studies have also relied greatly on the measure of serum anti-mullerian hormone (AMH) to evaluate the effect of cystectomy on ovarian reserve, as AMH is currently the most reliable marker to assess ovarian reserve. A significant difference was found between AMH before and following cystectomy in several studies. The deleterious effect of deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis in many cases, even when no cystectomy has been performed, is therefore not entirely ruled out. To the best of our knowledge, there are no studies on the effect of deep endometriosis surgery, apart from ovarian surgery, on ovarian reserve.

Our center is very active in the laparoscopic surgical treatment of deep endometriosis, with more than 200 cases every year. The objective of this trial is to assess the effect of deep endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by measuring serum AMH before and after surgery, at 6 months and 1 year post-operatively.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 37 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • female patient between 18 and 38 years
  • endometriosis stage III or IV in the AFSr classification
  • laparoscopy included deep endometriosis procedures (adhesiolysis, ureterolysis, cystectomy, resection of bowel, urinary or deep peritoneal endometriosis)
  • written informed consent

排除标准

  • previous adnexectomy or adnexectomy during surgery

结局指标

主要结局

Change from baseline in ovarian reserve (determined by AMH) at one year

时间窗: Baseline : before surgery (less than one month) and one year after surgery

次要结局

  • Percentage of decline in AMH between patients who underwent ovarian cystectomy and those who did not(baseline and 1 year after surgery)
  • Evolution curve of AMH at 6 months and 1 year post-operatively(baseline, 6 months and 1 year after surgery)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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