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Synchrotron Imaging of Human Ovaries Ex Situ

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01631786
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : September 22, 2014
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Angela Baerwald, University of Saskatchewan

Brief Summary:
Ultrasonography is currently the most common diagnostic tool for imaging the female reproductive tissues. However, clinical ultrasonography is limited to the detection of ovarian structures ≥ 2 mm, with an inability to image microanatomy including small antral follicles and oocytes. The objective of this study is to determine whether the synchrotron can be used to effectively image bovine and human ovaries ex situ. We hypothesize that synchrotron imaging will provide greater resolution and thereby allow the detection of fine structural details of the ovary compared to conventional ultrasonography. Ovaries will be imaged using conventional ultrasonography, synchrotron and histology. We anticipate that our results will provide important information about ovarian physiology which can be applied to the study of female reproductive dysfunctions.

Condition or disease
Abnormal Female Reproductive Function

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Preserved ovaries
Ovaries or ovarian segments that have been fixed in 10% Formalin
Fresh/non-preserved ovaries
Ovaries that have been surgically removed and placed in sterile saline

Primary Outcome Measures :
  1. Follicular counts [ Time Frame: July-Aug 2012 ]
    total number of antral ovarian follicles will be counted in the ultrasonographic and synchrotron images

Secondary Outcome Measures :
  1. 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

  2. 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
surgically removed human ovarian tissues and Formalin-fixed human ovarian tissues

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients in the Saskatoon Health Region

Inclusion Criteria:

  • women undergoing unilateral/bilateral oophorectomy at Saskatoon City Hospital or Royal University Hospital between May - August 2012

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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 identifier (NCT number): NCT01631786

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Canada, Saskatchewan
University of Saskatchewan, Canadian Light Source
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Angela R Baerwald, PhD University of Saskatchewan
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Responsible Party: Angela Baerwald, Assistant Professor, University of Saskatchewan Identifier: NCT01631786    
Other Study ID Numbers: CIHR-THRUST-ARB-001
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014
Keywords provided by Angela Baerwald, University of Saskatchewan: