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

February 22, 2024 updated by: Fertigo Medical Ltd
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah tikva, Israel
        • Rabin Medical Center
      • Reẖovot, Israel
        • Kaplan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study will include up to 200 women between the ages of 18 - 40, to be recruited from the general population and medical center patient population, after determination that they are suited to the study according to the inclusion/exclusion criteria, and after having given informed consent to participate in the study.

The sample size of the study will be determined such that adequate mapping of the 24 days of the menstrual cycle (putting more weight on luteal phase), excluding menstruation days (assuming a 28 day cycle), and dividing of the cohort into subgroups by age, can be achieved using the study methods described below, while adhering to financial constraints.

Description

Inclusion Criteria:

  1. Gender: Female
  2. Age: 18-40

  3. Belong to one of the three following groups:

    1. Women undergoing fertility treatment, and are regularly ovulating
    2. Women whose fertility status is unknown
    3. Women proved to be fertile (previous spontaneous successful pregnancy)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between image-based endometrial dating and that of histology
Time Frame: 12 months
Correlation coefficients and/or P-value levels
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fertigo Medical Ltd

Collaborators

Kaplan Medical Center

Investigators

  • Study Chair: Tsafrir S Kolatt, Ph.D., Fertigo Medical Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

June 6, 2021

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FER-CT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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