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临床试验/NCT03682614
NCT03682614已完成不适用

Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients With Normal Pathohistological Stage --Pilot Study

Reproductive & Genetic Hospital of CITIC-Xiangya1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年12月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
1
主要终点
clinical pregnancy rate

研究概览

简要总结

Repeated implantation failure(RIF) is a insurmountable bottleneck in assisted reproductive technology, many studies have considered that the cause of two-thirds of implantation failure is the decreased endometrial receptivity. After exclude some major local immune factors(NK,CD138 cells) and implantation window out of phase, There are still a part of patients infertile .Human chorionic gonadotropin (hCG) is an early pre-implantation signal molecule secreted by the embryo, it can promote endometrial proliferation, increase blood flow and promote embryonic adhesion and inhibit self-regulated apoptosis of trophoblast cells. Previous studies showed that: intrauterine injection of HCG before embryo transfer can improve clinical outcomes in IVF/Intracytoplasmic sperm injection(ICSI). But some studies found that the intrauterine injection of HCG can not significantly improve the success rate of blastocyst transfer, and the reason may be the intrauterine injection of HCG time is too late to significantly increase the implantation rate. Would ahead of intrauterine injection of HCG be more effective? Thus, the patients of repeated implantation frozen embryo cycle according to the random principle accepted two kinds of transplants ways: ①intrauterine injection of HCG before blastocyst transfer; ②blastocyst transfer. Try to understand whether intrauterine injection of HCG can significantly improve the clinical pregnancy rate of blastocyst transfer in repeated implantation failure patients.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • repeated implantation failure patients: ≥ 3 times IVF-embryo transfer failed to help pregnancy (biochemical or non-pregnant)
  • age ≤36 years old
  • normal histopathological stage (+5-7)
  • endometrial NK cell <4.5%
  • 0 endometrial CD138 positive cell
  • natural cycle frozen embryo transfer
  • frozen blastocysts (≥4BC) embryos ≥ 1

排除标准

  • Scar uterus (diverticulum or incision false lumen after cesarean section)
  • intrauterine adhesions
  • untreated hydrosalpinx
  • adenomyosis (endometrial displacement)
  • endometritis
  • uterine fibroids compress the endometrium

研究组 & 干预措施

HCG group

Experimental

All patients will accept HCG 500IU intrauterine injection 2 days before blastocyte transfer

干预措施: HCG (Drug)

control group

Placebo Comparator

All patients will accept same dose of culture medium intrauterine injection 2 days before blastocyte transfer

干预措施: culture medium (Other)

结局指标

主要结局

clinical pregnancy rate

时间窗: 28 days after blastocyst transfer

次要结局

  • clinical implantation rate(28 days after blastocyst transfer)
  • ongoing pregnancy rate(70 days after blastocyst transfer)
  • ectopic pregnancy rate(within 3 months after blastocyst transfer)
  • abortion rate(within 28 weeks after blastocyst transfer)

研究者

发起方
Reproductive & Genetic Hospital of CITIC-Xiangya
申办方类型
Other
责任方
Sponsor

研究点 (1)

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