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临床试验/NCT03504345
NCT03504345Unknown不适用

Assessing the Optimal Duration of Progesterone Supplementation Prior to Transfer of Frozen Embryos in the Recurrent Implantation Failure Population

Mount Sinai Hospital, Canada0 个研究点目标入组 240 人开始时间: 2018年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
240
主要终点
clinical pregnancy rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Previous testing with Endometrial Receptivity Assay (ERA)
  • Unable understand/communicate in English

研究组 & 干预措施

Control Group

Active Comparator

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.

干预措施: Prometrium (Drug)

Experimental Group

Experimental

This arm of the study will have their frozen-thawed embryo transfer take place on the seventh day of progesterone supplementation (Prometrium).

干预措施: Prometrium (Drug)

结局指标

主要结局

clinical pregnancy rate

时间窗: 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.

次要结局

  • Live birth rate(Approximately 9 months after embryo transfer)
  • Miscarriage rate(Approximately 3 months after embryo transfer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystal Chan

Clinician Investigator, Assistant Professor, Department of Obstetrics & Gynaecology

Mount Sinai Hospital, Canada

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