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临床试验/NCT03191890
NCT03191890撤回不适用

Observational, Non-Interventional, Prospective, Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device for Participants With Subfertility Issue Undergoing Assisted Reproductive Medical Treatment in Routine Clinical Practice

Anecova SA1 个研究点 分布在 1 个国家开始时间: 2017年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Fertilization rate

研究概览

简要总结

This study is designed to generate a comprehensive survey of the use on the market of the Anecova device within its intended indications according to the Instructions For Use. The Anecova Registry is part of the Anecova quality system, to enable the Post Marketing Surveillance and the Post Market Clinical Follow-up.

详细描述

As soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place.

These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female DNA and the chromosome segregation on the newly formed mitotic spindle.

If any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy.

In vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions.

The Registry will capture information from the Anecova procedure, from the outcomes, from the procedure performance, from the safety and from the utilization of the Anecova Medical Device in clinical routine.

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 43 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Age between 18 and 43,
  • •Hormonal serum levels within normal ranges for the routinely or specifically tested hormones (FSH, LH, AMH, E2, PRL, P4, TSH),
  • •BMI between 18 and 29, If assessed normal antral follicular count and regular menses

排除标准

  • •Endometrial, autoimmune or hormonal specificities, as well as presence of pathology that could be potentially deleterious to the healthy development of embryos in the uterine cavity (i.e. severe endometriosis),
  • •Acute or chronic gynecological infection

结局指标

主要结局

Fertilization rate

时间窗: 1 day

Number of zygotes over all transferred injected/inseminated oocytes

次要结局

  • Biochemical Pregnancy rate(15 days)
  • Implantation rate(5 weeks)
  • Clinical pregnancy rate(9 weeks)

研究者

发起方
Anecova SA
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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