Fertility Preservation in Case of Endometriosis : Observational Cohort Study
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
- characteristics of patients who will benefit from preservation fertility in case of endometriosis (age, parameters of ovarian reserve, endometriosis stage and lesions, previous treatment or surgeries, previous fertility treatment)
研究概览
简要总结
Fertility Preservation is now considered as crucial for the well-being of women battling cancer. However, others indications have more recently emerged. Women with endometriosis may represent a suitable group since they are at risk for compromise ovarian reserve. Data on FP in endometriosis patients are rare: only small retrospective study, case-reports and opinion publications .Nowadays, there is no available data concerning real indications for PF on endometriosis patients (endometriomas, risk of surgery, deep endometriosis?), criteria for eligibility (ovarian reserve parameters, age), quality of oocytes and number of oocytes necessary to give at least one live birth.
We propose a monocentric observational cohort study, evaluating the efficacy of oocytes cryopreservation as fertility preservation procedure, in young adult female subjects with endometriosis, to finally define the criteria of eligibility for PF procedures in case of endometriosis.
详细描述
Monocentric observational cohort study, enrolling young patients with endometriosis, without birth project for the moment, and asking for fertility preservation, in order to preserve mature oocytes.
Protocol of this study :
- information and signatures of consent file ;
- ovarian stimulation, oocytes retrieval and mature oocytes cryopreservation (one or more procedures)
- questionnaires every year, describing quality of life in this context of endometriosis and evolution (treatment, surgery, ART, pregnancies)
- data about number and rate of thawed oocytes after preservation, pregnancy rate and live birth rate with these oocytes.
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 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women from 18 to 36 years old
- •endometriosis disease proved by sonography, MRI and/or surgery
- •Consenting to participate to the study
排除标准
- •Any contraindication for ovarian stimulation.
- •Any contraindication for pregnancy .- Impossible Follow-up.
结局指标
主要结局
characteristics of patients who will benefit from preservation fertility in case of endometriosis (age, parameters of ovarian reserve, endometriosis stage and lesions, previous treatment or surgeries, previous fertility treatment)
时间窗: 5 years
baseline data
次要结局
- Events between fertility preservation and re-use or end of the study 5(5 years)
- rate of patients who will re-use their cryopreserved oocytes(5 years)
- oocytes survival rate(5 years)
- live birth rate(5 years)
- Events between fertility preservation and re-use or end of the study 1(5 years)
- Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire(5 years)
- Events between fertility preservation and re-use or end of the study 2(5 years)
- Events between fertility preservation and re-use or end of the study 3(5 years)
- Events between fertility preservation and re-use or end of the study 4(5 years)
- pregnancy rate(5 years)
- birth rate(5 years)