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临床试验/NCT03128970
NCT03128970已完成不适用

Synchronizing Blastocyst at Hatching Stage in Frozen Embryo Transfer Cycles

Al-Yasmeen Fertility and Gynecology Center2 个研究点 分布在 1 个国家目标入组 742 人开始时间: 2017年4月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
742
试验地点
2
主要终点
Ongoing implantation rate

研究概览

简要总结

The aim of the present study is to determine if implantation rate could be increased in women undergoing frozen embryo transfer cycles in case of adjusting their embryo development at hatching stage.

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
Double (Participant, Care Provider)

盲法说明

The gynecologist performing the embryo transfer as well as the patients undergoing frozen embryo transfer will be blinded to group allocation

入排标准

年龄范围
19 Years 至 33 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who will agree to participate and assign an informed consent form
  • Only blastocyst transfer FET cycles
  • Patients undergoing FET after their 1st IVF or ICSI cycle with no pregnancy at the fresh transfer
  • Freeze-all cycles due to OHSS
  • Freeze-all cycles due to poor endometrium
  • Age 19-33 at the time of randomization.
  • Their frozen blastocysts are 3 or less grade of expansion.
  • Female with a ≥12 AFCs
  • Endometrial thickness ≥ 8mm at the time of ovulation
  • Women with their male partners will give only fresh semen
  • Women who have no uterine abnormality by ultrasound

排除标准

  • Cycles undergoing preimplantation genetic diagnosis.
  • Women who have previous two cycles of implantation failure at fresh transfer
  • Women who have previous two FET failed cycles
  • Any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities)
  • Patients with severe endometriosis
  • Presence of uni- or bilateral hydrosalpinx
  • Recurrent pregnancy loss.
  • Any medical condition that affect fertility.

研究组 & 干预措施

frozen/thawed

No Intervention

blastocysts with three or less grade of expansion will be thawed and then subsequently transferred into women uterus three hours post-thawing.

synchronized frozen/thawed hatching blastocysts

Experimental

blastocyst thawing (with three or less grade of expansion) will take place the day before embryo transfer in order to reach hatching stage

干预措施: synchronizing blastocysts (Other)

结局指标

主要结局

Ongoing implantation rate

时间窗: 12 weeks

ultrasound detection of ongoing gestational sacs with heartbeats after 12 weeks of gestation per transferred embryos

次要结局

未报告次要终点

研究者

发起方
Al-Yasmeen Fertility and Gynecology Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasmin Magdi

Dr

Al-Yasmeen Fertility and Gynecology Center

研究点 (2)

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