Fertility Preservation in Case of Endometriosis (PREFENDO)
Fertility Preservation in Case of Endometriosis : Observational Cohort Study
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Emmanuelle Mathieu d'Argent, MD
- 电话号码：+33 156 01 68 69
- 邮箱：emmanuelle.mathieu@aphp.fr
研究联系人备份
- 姓名：Emile Darai, MD, PhD
- 邮箱：emile.darai@tnn.aphp.fr
学习地点
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Ile De France
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Paris、Ile De France、法国、75020
- 招聘中
- Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON
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接触：
- Emmanuelle Mathieu d'Argent, MD
- 电话号码：+33 156 01 68 69
- 邮箱：emmadargent@gmail.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- women from 18 to 36 years old
- endometriosis disease proved by sonography, MRI and/or surgery
- Consenting to participate to the study
Exclusion Criteria:
- Any contraindication for ovarian stimulation.
- Any contraindication for pregnancy .- Impossible Follow-up.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Women with endometriosis
Women with endometriosis disease aged 18-36 years, with appropriate endometriosis diagnosis, based on transvaginal sonography, magnetic resonance imaging and/or previous surgery.Ovarian reserve was assessed by antral follicle counting (AFC) and measurement of serum anti-Mullerian hormone (AMH) levels Enrolled after preservation fertility procedure (vitrification of mature oocytes)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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)
大体时间：5 years
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baseline data
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5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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rate of patients who will re-use their cryopreserved oocytes
大体时间：5 years
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follow up data
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5 years
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oocytes survival rate
大体时间：5 years
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follow up data
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5 years
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pregnancy rate
大体时间：5 years
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follow up data
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5 years
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birth rate
大体时间：5 years
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follow up data
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5 years
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live birth rate
大体时间：5 years
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follow up data
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5 years
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Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire
大体时间：5 years
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Patients complete a SF-36 questionnaire
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5 years
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Events between fertility preservation and re-use or end of the study 1
大体时间：5 years
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Nature of surgical procedures for endometriosis during the year
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5 years
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Events between fertility preservation and re-use or end of the study 2
大体时间：5 years
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Number of surgical procedures for endometriosis during the year
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5 years
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Events between fertility preservation and re-use or end of the study 3
大体时间：5 years
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Pregnancy during the year (and type of pregnancy: abortion, clinical pregnancy, delivery)
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5 years
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Events between fertility preservation and re-use or end of the study 4
大体时间：5 years
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Duration of medical treatement for endometriosis during the year: number of months during the year
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5 years
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Events between fertility preservation and re-use or end of the study 5
大体时间：5 years
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Type of medical treatement for endometriosis during the year: class of molecule
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5 years
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合作者和调查者
调查人员
- 首席研究员：Emmanuelle Mathieu d'Argent, MD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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