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临床试验/NCT06106919
NCT06106919已完成不适用

PFENDO : Ovarian Blockade During Fertility Preservation in Patients With Endometriosis: a Retrospective Non-inferiority Comparative Study

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
Number of mature oocytes collected by ovarian puncture

研究概览

简要总结

The aim of the study is to demonstrate the non-inferiority of dienogest on the number of mature oocytes collected compared with "conventional" ovarian stimulation protocols (using a GnRH agonist or antagonist), in patients with endometriosis in a fertility preservation context.

详细描述

Endometriosis is a common pathology affecting 1 in 10 women of childbearing age, and is responsible for around 40% of infertility cases.

The impact of endometriosis on fertility has now been clearly demonstrated, making it a medical indication for fertility preservation.

Today, dienogest is a key element in the therapeutic arsenal, helping to alleviate painful symptoms, reduce endometriosis lesions and improve patients' quality of life.

By creating a hypo-oestrogenic and hyperprogestogenic climate, dienogest at a daily dose of 2mg not only atrophies the endometrial tissue of endometriotic lesions, but also inhibits ovulation, enabling it to be used as an adjuvant treatment to ovarian stimulation.

There are currently 3 protocols commonly used during ovarian stimulation for oocyte self-preservation: the antagonist protocol (using a GnRH antagonist), the agonist protocol (using a GnRH agonist) and the PPOS protocol (using a progestin, which may be dienogest). In patients undergoing long-term dienogest therapy, the first 2 protocols require discontinuation of background treatment, which entails a risk of recurrence of symptoms and progression of endometriosis lesions, unlike the PPOS protocol, which allows dienogest treatment to be continued during stimulation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient aged between 18 and 42 inclusive
  • Patient with endometriosis
  • Patient who has undergone at least one cycle of ovarian stimulation for fertility preservation between June 2022 and September 2023 inclusive, using one of the protocols studied:
  • GnRH agonist GnRH antagonist Dienogest

排除标准

  • Non-medical or medical fertility preservation excluding endometriosis

结局指标

主要结局

Number of mature oocytes collected by ovarian puncture

时间窗: through study completion, an average of 15 days

Number of mature oocytes

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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