Clinical trial NCT01631786: Synchrotron Imaging of Human Ovaries Ex Situ
Official title: Synchrotron Imaging of Human Ovaries Ex Situ
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abnormal Female Reproductive Function
Keywords: Ovaries
Imaging
Ultrasonography
Synchrotron
Histology
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-06-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the Saskatoon Health Region

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Follicular counts
timeFrame: July-Aug 2012
Secondary outcomes:
measure: Diameter measurements
timeFrame: July-Aug 2012
measure: Microanatomy of ovarian tissues
timeFrame: July -Aug 2013
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan, Canadian Light Source
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Angela R Baerwald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh J, Adams GP, Pierson RA. Promise of new imaging technologies for assessing ovarian function. Anim Reprod Sci. 2003 Oct 15;78(3-4):371-99. doi: 10.1016/s0378-4320(03)00100-3.