Clinical trial NCT04288843: Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants
Official title: Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrium
Keywords: Endometrial dating
Lead sponsor: Fertigo Medical Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kaplan Medical Center
First posted: 2020-02-28
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between image-based endometrial dating and that of histology
timeFrame: 12 months
Secondary outcomes:
measure: Correlation between image-based endometrial dating and other collected data
timeFrame: 12 months
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Fertigo Medical Ltd
name: Tsafrir S Kolatt, Ph.D.
role: STUDY_CHAIR
References: