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

Endometrium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288843
• Other study ID #: FER-CT-001
• Status: Completed
• Start date: June 16, 2019
• Est. completion date: June 6, 2021

Study information

• Verified date: March 2022
• Source: Fertigo Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 6, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrium

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah tikva
Israel	Kaplan Medical Center	Re?ovot

Sponsors (2)

Lead Sponsor	Collaborator
Fertigo Medical Ltd	Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between image-based endometrial dating and that of histology	Correlation coefficients and/or P-value levels	12 months
Secondary	Correlation between image-based endometrial dating and other collected data	Collected data: hormonal profile, ultrasound images, subject self-reporting of cycle date	12 months