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

• Sponsor: Fertigo Medical Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04288843
• Collaborator: Kaplan Medical Center (Other)
• Enrollment: 49
• Locations: 2
• Actual Duration (Months): 23.7
• Patients Per Site: 24.5
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 49 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants
• Actual Study Start Date: Jun 16, 2019
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Jun 6, 2021

Outcome Measures

Primary Outcome Measures

1. Correlation between image-based endometrial dating and that of histology [12 months]

   Correlation coefficients and/or P-value levels

Secondary Outcome Measures

1. Correlation between image-based endometrial dating and other collected data [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Gender: Female

2. Age: 18-40

3. Belong to one of the three following groups:

4. Women undergoing fertility treatment, and are regularly ovulating

5. Women whose fertility status is unknown

6. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petah tikva		Israel
2	Kaplan Medical Center	Reẖovot		Israel

Sponsors and Collaborators

• Fertigo Medical Ltd
• Kaplan Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fertigo Medical Ltd
• ClinicalTrials.gov Identifier: NCT04288843
• Other Study ID Numbers: FER-CT-001
• First Posted: Feb 28, 2020
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fertigo Medical Ltd: Endometrial dating

Study Results

No Results Posted as of Mar 16, 2022