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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04288843

Enrollment

Registered

2020-02-28

Start date

2019-06-16

Completion date

2021-06-06

Last updated

2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrium

Keywords

Endometrial dating

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Outcome results