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