Synchrotron Imaging of Human Ovaries Ex Situ

Abnormal Female Reproductive Function Clinical Trial

Official title:

Synchrotron Imaging of Human Ovaries Ex Situ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631786
• Other study ID #: CIHR-THRUST-ARB-001
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: September 19, 2014
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abnormal Female Reproductive Function

Locations

Country	Name	City	State
Canada	University of Saskatchewan, Canadian Light Source	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follicular counts	total number of antral ovarian follicles will be counted in the ultrasonographic and synchrotron images	July-Aug 2012	No
Secondary	Diameter measurements	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	July-Aug 2012	No
Secondary	Microanatomy of ovarian tissues	Qualitative and quantitative evaluations of ovarian microanatomy using histology. Histological evaluations will be compared with synchrotron images.	July -Aug 2013	No