Synchrotron Imaging of Human Ovaries Ex Situ
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|ClinicalTrials.gov Identifier: NCT01631786|
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : September 22, 2014
|Condition or disease|
|Abnormal Female Reproductive Function|
The objective of our research is to determine whether the synchrotron is an effective tool for imaging human ovaries ex situ. Approximately 1 in every 6 women in Canada is affected by infertility; however, the underlying causes remain largely unknown. Imaging techniques are essential for increasing our understanding of normal and abnormal female reproductive biology. At present, ultrasonography is the most commonly-used tool to image human ovaries. However, ultrasonography only allows the detection of structures ≥ 2 mm in size within the ovaries, limiting the ability to detect smaller anatomic details (eg. the eggs and the surrounding cells and 'follicles' or the small fluid filled sacs that contain the eggs). Other limitations of ultrasonography for imaging the ovaries include a limited depth of penetration within the pelvis and the inability to see the ovaries clearly due to bowel activity and/or gas.
The synchrotron has been effectively used for imaging soft tissues, including the breast, heart and lungs. We hypothesize that the synchrotron will provide greater resolution for imaging the ovaries compared to conventional ultrasonography. Specifically, we anticipate that synchrotron imaging will provide greater structural details of the ovaries (including small follicles <2 mm and eggs) compared to conventional ultrasonography.
The study will consist of three different phases listed below:
- Phase 1 - Imaging of 10 fresh and preserved bovine ovaries
- Phase 2 - Imaging of 5 preserved human ovaries from the Department of Pathology
- Phase 3 - Imaging of 2-4 fresh human ovaries from women having their ovaries surgically removed
The initial imaging of bovine ovaries will help us determine the best synchrotron settings to image the human samples. All ovaries will be preserved using formaldehyde. In all 3 study phases, ovarian specimens will be imaged first with 2D and 3D ultrasonography and then with the Biomedical Imaging and Therapy Beamline (BMIT) at the Canadian Light Source. Furthermore, histologic sections of structures of interest within the ovaries will be made, and digital images will be acquired.
We believe that synchrotron imaging of human ovaries ex situ will be an important first step to develop future high-resolution tools for imaging reproductive tissues in situ.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Synchrotron Imaging of Human Ovaries Ex Situ|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2013|
Ovaries or ovarian segments that have been fixed in 10% Formalin
Ovaries that have been surgically removed and placed in sterile saline
- Follicular counts [ Time Frame: July-Aug 2012 ]total number of antral ovarian follicles will be counted in the ultrasonographic and synchrotron images
- Diameter measurements [ Time Frame: July-Aug 2012 ]The diameters of ovarian follicles, cell layers of the follicle wall, corpora lutea, and cumulus oocyte complexes will be measured using ultrasonographic, synchrotron and histologic images
- Microanatomy of ovarian tissues [ Time Frame: July -Aug 2013 ]Qualitative and quantitative evaluations of ovarian microanatomy using histology. Histological evaluations will be compared with synchrotron images.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631786
|University of Saskatchewan, Canadian Light Source|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||Angela R Baerwald, PhD||University of Saskatchewan|