New Device to Maintain the Embryo Temperature During Transfer (EmbryoTemp)
A New System for Preventing Thermal Stress During Embryo Transfer
The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.
The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.
With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jorge Ten Morro, Ph.D.
- 电话号码：696914882
- 邮箱：jten@institutobernabeu.com
研究联系人备份
- 姓名：Jorge Ten Morro, Ph.D
- 电话号码：696914882
- 邮箱：jten@institutobernabeu.com
学习地点
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Alicante、西班牙、03016
- 招聘中
- Instituto Bernabeu
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接触：
- Rafael Bernabeu, M.D., Ph.D.
- 电话号码：+34965154000
- 邮箱：rbernabeu@institutobernabeu.com
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接触：
- Rafael Bernabeu, M.D., Ph.D
- 电话号码：+34965154000
- 邮箱：rbernabeu@institutobernabeu.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
描述
Inclusion Criteria:
- Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.
Exclusion Criteria:
- Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Conventional transfer
This arm is the control group (conventional embryo transfer protocol) where there is no intervention.
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实验性的：Thermostable device transfer
This arm is the study group: embryo transfer protocol using a new thermostable device.
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Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature
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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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Ongoing Pregnancy rate
大体时间：Ongoing pregnancy until 28th week of gestation
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Achieving an ongoing pregnancy after embryo transfer
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Ongoing pregnancy until 28th week of gestation
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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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Miscarriage rate
大体时间：Loss of pregnancy up to 12 weeks of gestation
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To know the embryonic loss rate after implantation
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Loss of pregnancy up to 12 weeks of gestation
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Implantation rate
大体时间：Embryo implantation after 6-7 weeks of gestation
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To know the embryo implantation rate after the embryo transfer
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Embryo implantation after 6-7 weeks of gestation
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
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 (估计)
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
与本研究相关的术语
其他研究编号
- Instituto Bernabeu Group
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Thermostable device的临床试验
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St. Louis UniversityLucerno Dynamics Limited Liability Company (LLC)完全的
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Taipei Veterans General Hospital, TaiwanLotung Poh-Ai Hospital未知
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University Hospital, Basel, SwitzerlandClinical Trial Unit, University Hospital Basel, Switzerland完全的