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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-16

Study Completion Date

2021-06-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometrium

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes