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临床试验/NCT04455191
NCT04455191Unknown不适用

Comparison of the Effects of Thawing Embryos in Advance and Thawing on the Day of Transfer on Pregnancy Outcomes in the Frozen Embryo Transfer Cycle

Jinan Central Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Clinical Pregnancy Rate (Pregnancy or Not)

研究概览

简要总结

Respectively for patients with repeated transplant failure and routine patients, Thawing frozen embryos in advance (18h) to extend the duration of embryonic development or thawing embryos on the day of transfer in the frozen embryo transfer cycle, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two ways or two types of patients?

详细描述

Although in clinical practice, thawed embryos with appropriate development time will be selected strictly according to the number of days after ovulation, there are still two problems in actual clinical treatment: one is the embryonic factor, although the rate of embryonic development is generally the same, However, the phenomenon of delayed embryo division and development often occurs. The second is the endometrial factor. There are reports that a small number of people will move the transplant window forward, or the transplant window is narrow. This potentially creates the risk of embryo-endometrial mismatch. Based on this, the research team focused on patients with frozen embryo transfer cycles and put forward the strategy of "thawing embryos in advance and prolonging the development period of embryos properly" in an effort to achieve better repair of damage caused by embryo freezing and fine-tuning of embryo-endometrial interaction time. Therefore, it is necessary to compare thawing embryos in advance and thawing on the day of transfer on pregnancy outcomes in patients with repeated transplant failure and routine patients respectively.

The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two ways or two types of patients?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged <=35 years old;
  • Regular menstrual cycle;
  • Baseline follicle stimulating hormone (FSH) <12 IU/L;
  • Infertility, pure fallopian tube or/and male factor;
  • At least 2 high-quality day 3 embryos or 1 high-quality day 5 blastocyst are used for ET.

排除标准

  • Patients with repeated transplant failure:
  • Abnormal uterus, such as adenomyosis, endometriosis, endometrial polyps or Asherman syndrome;
  • Abnormal ovaries, such as low ovarian response and polycystic ovary syndrome (PCOS);
  • The endometrial thickness of FET day is <7 mm.

结局指标

主要结局

Clinical Pregnancy Rate (Pregnancy or Not)

时间窗: 6 weeks

Observe the clinical pregnancy rate under different embryo thawing time

Live Birth Rate (Birth or Not)

时间窗: 40 weeks

Observe the live birth rate under different embryo thawing time

次要结局

未报告次要终点

研究者

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

Bin Wu

Reproductive medicine department

Jinan Central Hospital

研究点 (1)

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