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Completed

NCT Number: NCT04288843

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

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.

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Key information

Conditions

Endometrium

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Rabin Medical Center, Petah Tikva, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gender: Female
  • Age: 18-40
  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Correlation between image-based endometrial dating and that of histology

    Time frame: 12 months

    Correlation coefficients and/or P-value levels

Secondary outcomes

  1. Correlation between image-based endometrial dating and other collected data

    Time frame: 12 months

    Collected data: hormonal profile, ultrasound images, subject self-reporting of cycle date

Sponsors and collaborators

Lead sponsor

Fertigo Medical Ltd

Industry

Collaborators

  • Kaplan Medical Center

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 28, 2020
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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