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临床试验/NCT05632731
NCT05632731尚未招募不适用

Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study

Women's Hospital School Of Medicine Zhejiang University0 个研究点目标入组 1,236 人开始时间: 2022年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,236
主要终点
live birth rate per fresh transfer

研究概览

简要总结

In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate.The purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.

详细描述

In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that in the fresh cleavage embryo transfer cycle, the clinical pregnancy rate increased with the increase of the number of high-quality embryos transferred, and so did the multiple pregnancy rate, suggesting that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate. Compared with the embryo at cleavage stage, blastocyst culture is a process of survival of the fittest, which is physiologically more synchronized with endometrial development and can improve embryo implantation rate.

The existing clinical research analysis is mostly limited to the down-regulating regimen, while the RCT study of high-quality with GnRH antagonist protocol is few. Therefore, the purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with a diagnosis of primary or secondary infertility with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI)
  • under 38 years of age
  • number of AFC≥6, AMH>1.1ng/ml
  • no adverse factors of fresh embryo transplantation (evaluation by an experienced reproductive physician)
  • number of available embryos(day 3)≥4
  • informed consent

排除标准

  • with adenomyosis, endometrial compression by uterine fibroids, intrauterine adhesion, endometrial polyps and other factors unsuitable for fresh cycle transplantation

结局指标

主要结局

live birth rate per fresh transfer

时间窗: 2 year

live birth, which was defined as the presence of a live fetus (or feti) after the 24th week of gestational age

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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