Synchrotron Imaging of Human Ovaries Ex Situ

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Angela Baerwald, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01631786
First received: June 27, 2012
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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
Abnormal Female Reproductive Function

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Synchrotron Imaging of Human Ovaries Ex Situ

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Follicular counts [ Time Frame: July-Aug 2012 ] [ Designated as safety issue: No ]
    total number of antral ovarian follicles will be counted in the ultrasonographic and synchrotron images


Secondary Outcome Measures:
  • Diameter measurements [ Time Frame: July-Aug 2012 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients in the Saskatoon Health Region

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01631786

Locations
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)
Investigators
Principal Investigator: Angela R Baerwald, PhD University of Saskatchewan
  More Information

Publications:
Responsible Party: Angela Baerwald, Assistant Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01631786     History of Changes
Other Study ID Numbers: CIHR-THRUST-ARB-001
Study First Received: June 27, 2012
Last Updated: April 9, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Saskatchewan:
Ovaries
Imaging
Ultrasonography
Synchrotron
Histology

ClinicalTrials.gov processed this record on August 26, 2014