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临床试验/NCT05148624
NCT05148624已完成不适用

Comparative Study Between Short-time Bed Rest and Immediate Ambulation After Embryo Transfer Procedure. A Randomized Controlled Trial

Dubai Fertility Center2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2021年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
试验地点
2
主要终点
Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 10 weeks' gestation

研究概览

简要总结

Bed rest after embryo transfer (ET) has been clinically advised without robust scientific evidence. In investigators' unit, post ET instructions are given immediately after ET to sub-fertile women while lying in bed. The aim of the study is to compare the reproductive outcome of this practice compared with immediate ambulation and giving instructions after emptying the bladder.

详细描述

Bed rest after embryo transfers has been clinically advised without robust scientific evidence. Most of the assisted reproductive units routinely recommend a variable period of bedrest immediately after embryo transfer (ET) procedure without clear scientific evidence of its benefit. Three Randomized controlled trials (RCT) that included 712 embryo transfers with variable duration of bedrest did not report a benefit in pregnancy outcome. Only one study, however compared bedrest with no bedrest. In contrast, a 2013 RCT reported a harmful effect on the pregnancy outcome.

However, data on patients using embryos derived from their own oocytes are limited. In addition, there was no subgroup analysis to exclude confounding factors like number of oocytes retrieved and quality of embryos transferred. Few of these studies included embryos transferred after preimplantation genetic diagnosis.

The rationale behind bedrest come from the belief that decreased physical activity will help in embryo retention within the uterine cavity after replacement6. Ultrasound examination before and after ET with immediate ambulation did not show any uterine displacement of the air bubble. if gravity displaces transferred embryos, then staying with full bladder in supine position will make the anteverted ante flexed uterus more horizontal and increase the gravity effect.

Moreover, although bed rest is one of the most practiced treatments to improve reproductive outcome, most clinicians consider it the least crucial factor.

In investigators' unit, post ET instructions, which, may take up to 5 minutes, are practiced immediately after ET to patients while lying in bed. The aim of the study is to compare the effect of this practice with immediate ambulation and giving instructions after emptying the bladder in a sitting position on the reproductive outcome in patients undergoing assisted reproductive treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Couple undergoing In vitro fertilization, Intracytoplasmic sperm injection, Frozen embryo replacement or Frozen Intracytoplasmic sperm injection
  • Age between 20 to 40-year-old
  • Couples who are willingly accepting to participate in the study. Both husband and wife will sign the consent.

排除标准

  • Women with diminished ovarian reserve (AMH < 1.2 ng/ml or AFC < 7)
  • Women with unilateral or bilateral hydro salpinx
  • Women with bilateral endometriomas
  • Women with adenomyosis
  • Women with large (more than 3 cm uterine fibroid)
  • Women with fluid or polyp in the uterine cavity
  • Women with known chronic endometritis
  • Women with H/O recurrent >2 pregnancy loss or implantation failure
  • Were enrolled in this study before

结局指标

主要结局

Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 10 weeks' gestation

时间窗: 14 weeks

Ongoing pregnancy will be defined as a viable pregnancy detected by ultrasound examination between 10 - 13 weeks' gestation. The two groups will be compared using relative risk with 95% confidence interval.

次要结局

  • Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 6 weeks' gestation(6 weeks)
  • Percentage of participants who received or did not receive bed rest after embryo transfer who aborted before 12 weeks' gestation(12 weeks)

研究者

发起方
Dubai Fertility Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Elkalyoubi

Consultant Obs Gyn and reproductive medicine - Head of Medical Affair

Dubai Fertility Center

研究点 (2)

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