Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Number of mature oocytes eligible for cryopreservation
研究概览
简要总结
Benign ovarian cysts are frequent during women's life. They are diagnosed with pelvic pain or fortuitously during an ultra-sonographic exam. In case of persistence,a surgery will be necessary to identify the nature of the cyst and assess its benignity. In some case, cysts are recurrent and multiple surgeries are needed leading to a significant risk of ovarian damage by follicular depletion. Oocyte cryopreservation is no longer considered as an experimental technique of Fertility Preservation since 2013 as it has been recognized to be efficient and safe. According to reproductive medicine scientific committees and the French ethic law, fertility preservation has to be proposed in every situation of infertility risk. To date, there is no cohort study dedicated to fertility preservation by oocyte freezing in this specific subgroup of patients. The purpose of the study is to prospectively evaluate the oocyte number and quality after controlled ovarian hyperstimulation in patients with recurrent ovarian cysts.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with benign ovarian tumor with high risk of recurrence, i-e, endometrioma, dermoid cysts or mucinous cysts.
- •women with previous surgery and/or high risk of ovarian damage: bilateral cysts, cyst diameter higher than 5 cms
- •Having a social insurance
- •Able to give an informed consent
排除标准
- •Borderline tumors
- •Undetectable AMH levels
- •Personal history of thrombo-embolic events
- •pregnancy
结局指标
主要结局
Number of mature oocytes eligible for cryopreservation
时间窗: After 15 days of controlled ovarian hyperstimulation (COH)
次要结局
- Percentage of immature or morphologically abnormal oocytes(Real-time, the day of egg retrieval)
- Questionnaire on tolerance and complications(One week after the egg retrieval)
- Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulation(The day of HCG triggering at the end of ovarian stimulation)