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

Completed

• Conditions: Endometrium

• Registration Number: NCT04288843
• Lead Sponsor: Fertigo Medical Ltd

Brief Summary

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.

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 Timeline

• Study Start: 2019-06-16
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-06
• Status Verified: 2022-03
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between image-based endometrial dating and that of histology	12 months	Correlation coefficients and/or P-value levels

Secondary Outcome Measures

Name	Time	Method
Correlation between image-based endometrial dating and other collected data	12 months	Collected data: hormonal profile, ultrasound images, subject self-reporting of cycle date

Trial Locations

Locations (2)

Rabin Medical Center; 🇮🇱 Petah tikva, Israel

Kaplan Medical Center; 🇮🇱 Reẖovot, Israel