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临床试验/NCT06476379
NCT06476379已完成不适用

Can the Origin of Sperm - Ejaculated or Testicular- Affect Embryo Ploidy in Patients With Severe Male Factor Infertility?

Ganin Fertility Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月25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
100
试验地点
2
主要终点
Euploidy rate

研究概览

简要总结

There is evidence indicating that sperm plays a role in determining blastocyst ploidy status. In our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (PGT-A) and the subsequent clinical outcomes following transfers of euploid embryos. This comparison will be conducted between cases where ejaculated sperm and cases where testicular sperm were used for intracytoplasmic sperm injection (ICSI), specifically focusing on severe male factor infertility patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cases planned to have ICSI PGT-A cycles
  • Males diagnosed as severe male factor infertility
  • Normo responder female partners

排除标准

  • Leukocytospermia
  • Presence of varicocele.
  • Known genetic abnormality
  • Use of sperm or oocyte donors
  • Use of gestational carrier
  • Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
  • Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

结局指标

主要结局

Euploidy rate

时间窗: 15 days post ICSI

Defined as the proportion of euploid blastocysts

Aneuploidy rate

时间窗: 15 days post ICSI

Defined as the proportion of aneuploid blastocysts

Low mosaic rate

时间窗: Time Frame: 15 days post ICSI

Defined as the proportion of low mosaic blastocysts

High mosaic rate

时间窗: Time Frame: 15 days post ICSI

Defined as the proportion of high mosaic blastocysts

Implantation rate

时间窗: 6-9 weeks post-embryo transfer

defined as the percentage of successfully implanted embryos

Ongoing pregnancy rate

时间窗: 12 weeks of gestation

defined as a positive heartbeat on ultrasound beyond 12 weeks of gestation

Miscarriage rate

时间窗: after 6 weeks of gestation

defined as pregnancy loss following confirmation of clinical pregnancy

Clinical pregnancy rate

时间窗: 6-9 weeks post-embryo transfer

defined as the presence of a fetal heartbeat or gestational sac 6-9 weeks post-embryo transfer

次要结局

  • Fertilization rate(1 day)
  • Cleavage rate(3 days)
  • Blastocyst development rate(5-6 days)

研究者

发起方
Ganin Fertility Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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