Progesterone Supplementation in Frozen Embryo Transfer Cycles
Assessing the Optimal Duration of Progesterone Supplementation Prior to Transfer of Frozen Embryos in the Recurrent Implantation Failure Population
Recurrent implantation failure (RIF) occurs after women undergo in vitro fertilization and have multiple embryos transferred but no resulting pregnancies. RIF is a very challenging clinical entity for the reproductive physician and the patient. In fact, there is not even an agreed upon definition in the medical community. Many potential causes have been investigated over the past several years but no clear answer has emerged. Interest has recently turned to the endometrium, or the lining of the uterus. Studies have shown that the genes that are turned on in the endometrium vary based on how long this tissue has been exposed to progesterone, an important hormone that prepares the uterine lining for implantation of the growing embryo. In some women, it seems that they require longer periods of progesterone exposure to reach the same state of readiness. We hypothesize that an even larger proportion of women in RIF population will require longer treatments with progesterone.
In this study, we will randomize women with RIF who are about to undergo a frozen embryo transfer to one of two groups. The first group will have their embryo transfer done on the standard sixth day of progesterone treatment. The other group will have their transfer done on the seventh day of progesterone. We will be comparing the clinical pregnancy rate of the two groups as well as the live birth rate and miscarriage rate. We expect that extending the progesterone treatment by one day will increase the pregnancy rate of women with RIF.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
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:
- Patient at Mount Sinai Fertility who wants to undertake a frozen embryo transfer
- History of recurrent implantation failure, defined as no pregnancy after three or more embryo transfers of four or more good quality blastocysts
Exclusion Criteria:
- Previous testing with Endometrial Receptivity Assay (ERA)
- Unable understand/communicate in English
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 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 |
|---|---|
|
有源比较器：Control Group
This arm of the study will have their frozen-thawed embryo transfer take place on the sixth day of progesterone supplementation (Prometrium), which is the standard protocol in our clinic.
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The intervention will involve delaying the transfer of a frozen-thawed embryo into the uterus to increase the duration of progesterone exposure.
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实验性的：Experimental Group
This arm of the study will have their frozen-thawed embryo transfer take place on the seventh day of progesterone supplementation (Prometrium).
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The intervention will involve delaying the transfer of a frozen-thawed embryo into the uterus to increase the duration of progesterone exposure.
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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 |
|---|---|---|
|
clinical pregnancy rate
大体时间：6 to 8 weeks after embryo transfer
|
Rate of pregnancy, evidenced by clinical (fetal heartbeat) or ultrasound parameters (ultrasound visualization of a gestational sac, embryonic pole with heartbeat).
It includes ectopic pregnancy.
|
6 to 8 weeks after embryo transfer
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Live birth rate
大体时间：Approximately 9 months after embryo transfer
|
Rate of birth in which a fetus is delivered with signs of life after complete expulsion or extraction from its mother, beyond 20 completed weeks of gestational age
|
Approximately 9 months after embryo transfer
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Miscarriage rate
大体时间：Approximately 3 months after embryo transfer
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Rate of natural death of embryo or fetus, after reaching clinical pregnancy stage and at or before 10 weeks gestation.
|
Approximately 3 months after embryo transfer
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
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
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.
Prometrium的临床试验
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完全的
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St Vincent's Hospital招聘中
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Kronos Longevity Research InstituteMayo Clinic; Albert Einstein College of Medicine; Yale University; Columbia University; Brigham and... 和其他合作者未知