Abnormal Female Reproductive FunctionNCT01631786
Synchrotron Imaging of Human Ovaries Ex Situ
An observational study of Abnormal Female Reproductive Function, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Female Reproductive Function
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in the Saskatoon Health Region
Who may be able to join
- women undergoing unilateral/bilateral oophorectomy at Saskatoon City Hospital or Royal University Hospital between May - August 2012
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Saskatchewan, Canadian Light Source
Saskatoon, Saskatchewan, S7N 0W8
About this study
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.
Read the 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
- Keywords
- Ovaries, Imaging, Ultrasonography, Synchrotron, Histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular counts
total number of antral ovarian follicles will be counted in the ultrasonographic and synchrotron images
Measured: July-Aug 2012
Secondary outcomes (2)
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
Measured: July-Aug 2012
Microanatomy of ovarian tissues
Qualitative and quantitative evaluations of ovarian microanatomy using histology. Histological evaluations will be compared with synchrotron images.
Measured: July -Aug 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abnormal Female Reproductive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Angela Baerwald, University of Saskatchewan
- Investigators
- Angela R Baerwald, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631786
- Sponsor's protocol ID
- CIHR-THRUST-ARB-001
- Status last verified
- Sep 2014
- First submitted
- 27 Jun 2012
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12818654
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchrotron Imaging of Human Ovaries Ex Situ
- ClinicalTrials.gov ID
- NCT01631786
- Acronym / sponsor ID
- CIHR-THRUST-ARB-001
- Conditions
- Abnormal Female Reproductive Function
- Keywords
- Ovaries, Imaging, Ultrasonography, Synchrotron, Histology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the Saskatoon Health Region
Key inclusion criteria (1 listed)
- women undergoing unilateral/bilateral oophorectomy at Saskatoon City Hospital or Royal University Hospital between May - August 2012
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Follicular counts
Time frame: July-Aug 2012
total number of antral ovarian follicles will be counted in the ultrasonographic and synchrotron images
2 secondary outcomes
Diameter measurements
Time frame: July-Aug 2012
Microanatomy of ovarian tissues
Time frame: July -Aug 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Background: PubMed 12818654Singh 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela R Baerwald, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Female Reproductive Function, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular counts (time frame: July-Aug 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.