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

NCT04288843 | Completed

• 1 other identifier: FER-CT-001
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometrium

Keywords

Endometrial dating

Outcome Measures

Primary Outcomes (1)

• Correlation between image-based endometrial dating and that of histology

  Correlation coefficients and/or P-value levels

  12 months

Secondary Outcomes (1)

• Correlation between image-based endometrial dating and other collected data

  12 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fertigo Medical Ltd: lead
• Kaplan Medical Center: collaborator

Study Sites (2)

Rabin Medical Center

Petah Tikva, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pipelle biopsy of the endometrium

Study Officials

• Tsafrir S Kolatt, Ph.D.

  Fertigo Medical Ltd

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: June 16, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 6, 2021
• Last Updated: February 23, 2024

Record last verified: 2022-03

Locations

IL (2)