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临床试验/NCT04288843
NCT04288843已完成不适用

Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants

Fertigo Medical Ltd2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2019年6月16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
49
试验地点
2
主要终点
Correlation between image-based endometrial dating and that of histology

研究概览

简要总结

To evaluate the correlation between cycle day determination by clinical signs, study participant testimony, endometrium histopathology biopsy and ex-vivo imaging of the uterus endometrium.

详细描述

In order to assess the efficacy of using ex-vivo endometrial imaging to determine optimal time for embryo transfer, two to four separate analyses, including imaging, and the current standard method of endometrial dating (ultrasound, histological and blood tests) will be performed as well as participant's testimony. Dating by hormonal profile (blood tests) will be contingent on availability of the tests for each subject. So shall be the ultrasound test. During the analysis data will be acquired for subsequent correlation analysis. In addition, a parallel in-vivo analysis, similar in methodology to the ex-vivo analysis, may be performed via imaging by hysteroscopy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gender: Female
  • Belong to one of the three following groups:
  • Women undergoing fertility treatment, and are regularly ovulating
  • Women whose fertility status is unknown
  • Women proved to be fertile (previous spontaneous successful pregnancy)

排除标准

  • Women with known existing endometrial pathology
  • Women with known history of infertility due to oligo-ovulation or anovulation.
  • Women with medical history of malignant tumors in their reproductive system
  • Women that are on any hormonal medications or treatments (excluding hormonal contraception in previous cycles)
  • Women that are on hormonal contraception treatment in their current cycle
  • Women with intrauterine device
  • Women menstruating on the day of the biopsy collection

结局指标

主要结局

Correlation between image-based endometrial dating and that of histology

时间窗: 12 months

Correlation coefficients and/or P-value levels

次要结局

  • Correlation between image-based endometrial dating and other collected data(12 months)

研究者

发起方
Fertigo Medical Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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