Assessing the Optimal Duration of Progesterone Supplementation Prior to Transfer of Frozen Embryos in the Recurrent Implantation Failure Population
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
- 是
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
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
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
Crystal Chan
Clinician Investigator, Assistant Professor, Department of Obstetrics & Gynaecology
Mount Sinai Hospital, Canada
