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临床试验/NCT05499988
NCT05499988招募中不适用

The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases

Ganin Fertility Center1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Blastocoele re-expansion degree

研究概览

简要总结

Morphometric measurement of blastocyst diameter was taken on the day of trophoectoderm biopsy. PGT-A was done using NGS platform, followed by thawing and transfer of euploid blastocyts. Follow up of the Pregnancy and implantation rates is done and recorded to study the correlation between the diameter and reproductive outcomes of the blastocyst.

详细描述

Blastocyst morphological grading proposed by Gardner and Schoolcraft including the expansion degree, inner cell mass, and trophoectoderm assessment has proved its importance. Blastocyst expansion degree that can presented in diameter is linked to the blastocyst implantation and overall success.

In order to evaluate the importance of blastocyst diameter in PGT-A cases, measurements will be taken on the day of trophoectoderm biopsy TE (diameter in μm), followed by TE biopsy using flicking technique. Next, PGT-A will be done using NGS platform and results will be confirmed using PGT-ai. Thawing of euploid blastocyst will take place and expansion degree, survival rate will be recorded. Patient will be followed up for the clinical pregnancy and implantation rates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Female aged 18-45 years old
  • Male aged 18-60 years old
  • ICSI cases having PGT-A for their blastocysts
  • Must have their blastocysts cultured in time lapse incubator

排除标准

  • 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
  • Use of donor oocytes or sperm
  • Use of gestational carrier

结局指标

主要结局

Blastocoele re-expansion degree

时间窗: Two hours post thawing

Defined as the degree of blastocoele re-expansion and presented in %

Implantation rate

时间窗: 6-8 weeks of pregnancy

Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.

Pregnancy rate

时间窗: 15 days post embryo transfer

Defined as clinical pregnancy per transfer

Blastocyst survival rate

时间窗: Two hours post thawing

Defined as the proportion of blastocysts that showed expansion degree ≥50% and their cells remained intact after thawing and re-expansion

次要结局

未报告次要终点

研究者

发起方
Ganin Fertility Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Hasanen

Embryologist

Ganin Fertility Center

研究点 (1)

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