Synchrotron Imaging of Human Ovaries Ex Situ

NCT ID: NCT01631786

Last Updated: 2014-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-06-30

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.

Conditions

Abnormal Female Reproductive Function

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Preserved ovaries

Ovaries or ovarian segments that have been fixed in 10% Formalin

No interventions assigned to this group

Fresh/non-preserved ovaries

Ovaries that have been surgically removed and placed in sterile saline

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Angela Baerwald

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela R Baerwald, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

University of Saskatchewan, Canadian Light Source

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 12818654 (View on PubMed)

Other Identifiers

CIHR-THRUST-ARB-001

Identifier Type: -

Identifier Source: org_study_id