Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/8/2017 |
| Start Date: | July 15, 2009 |
| End Date: | September 1, 2016 |
Background:
- The uterine cervix is composed of muscle and collagen, which change as women age and
under hormonal influences like puberty, pregnancy, and menopause. Yet even though
knowledge of structure of the cervix (especially the collagen network) is important to
detect problems that may affect pregnancy and other women s health issues, no
noninvasive techniques are available to evaluate such changes.
- A specially designed polarized camera attached to a conventional colposcope can be used
to take cervical images. Analyzing these images may enable researchers to better
visualize the collagen network in the cervix.
Objectives:
- To explore and gain experience with the use of a polarized imaging system to study
cervical structure.
- To evaluate the usefulness of a polarized imaging system in studying the cervical
structure of healthy nonpregnant women.
Eligibility:
- Adult females (at least 18 years of age) who are having regular menstrual cycles and are
not on hormonal medications.
Design:
- Images will be takes from the cervix in two different phases of menstruation cycle time,
one in the follicular phase (before ovulation) and another one in the luteal phase
(after ovulation).
- The images of the cervix will be taken with a vaginal speculum in place with the camera
attached to a colposcope. The colposcope will illuminate the cervix using polarized
light. Three random cervical locations will be photographed
- The uterine cervix is composed of muscle and collagen, which change as women age and
under hormonal influences like puberty, pregnancy, and menopause. Yet even though
knowledge of structure of the cervix (especially the collagen network) is important to
detect problems that may affect pregnancy and other women s health issues, no
noninvasive techniques are available to evaluate such changes.
- A specially designed polarized camera attached to a conventional colposcope can be used
to take cervical images. Analyzing these images may enable researchers to better
visualize the collagen network in the cervix.
Objectives:
- To explore and gain experience with the use of a polarized imaging system to study
cervical structure.
- To evaluate the usefulness of a polarized imaging system in studying the cervical
structure of healthy nonpregnant women.
Eligibility:
- Adult females (at least 18 years of age) who are having regular menstrual cycles and are
not on hormonal medications.
Design:
- Images will be takes from the cervix in two different phases of menstruation cycle time,
one in the follicular phase (before ovulation) and another one in the luteal phase
(after ovulation).
- The images of the cervix will be taken with a vaginal speculum in place with the camera
attached to a colposcope. The colposcope will illuminate the cervix using polarized
light. Three random cervical locations will be photographed
The uterine cervix is composed of muscle and collagen which changes as women age and under
hormonal influences like after puberty, during pregnancy, and with menopause. It has been
determined that during pregnancy, prior to cervical ripening, cross linked collagen fibrils
are organized in tight bundles which provide tensile strength, rigidity and stiffness. As the
cervix ripens in preparation for labor, cervical collagen concentration is decreases and
solubility increases. However, there are no noninvasive techniques available to evaluate such
structural changes especially of the collagen of cervix. Developing a non-invasive way to
evaluate the characteristics of cervical structure and collagen may aid in identifying women
who are at risk of early cervical dilation. A specially designed polarized camera attached to
a conventional colposcope can be used to take cervical images. Analyzing these images may
enable us to visualize the collagen network in cervix. The purpose of this study is to
explore the usefulness of polarized camera images in evaluating the cervical structure of
healthy women at different ages. After evaluating and validating this approach in healthy,
nonpregnant women, we plan to assess the cervical structure of pregnant women, some of whom
may be at risk of early cervical dilation.
hormonal influences like after puberty, during pregnancy, and with menopause. It has been
determined that during pregnancy, prior to cervical ripening, cross linked collagen fibrils
are organized in tight bundles which provide tensile strength, rigidity and stiffness. As the
cervix ripens in preparation for labor, cervical collagen concentration is decreases and
solubility increases. However, there are no noninvasive techniques available to evaluate such
structural changes especially of the collagen of cervix. Developing a non-invasive way to
evaluate the characteristics of cervical structure and collagen may aid in identifying women
who are at risk of early cervical dilation. A specially designed polarized camera attached to
a conventional colposcope can be used to take cervical images. Analyzing these images may
enable us to visualize the collagen network in cervix. The purpose of this study is to
explore the usefulness of polarized camera images in evaluating the cervical structure of
healthy women at different ages. After evaluating and validating this approach in healthy,
nonpregnant women, we plan to assess the cervical structure of pregnant women, some of whom
may be at risk of early cervical dilation.
- INCLUSION CRITERIA:
- Age female 18 year or greater including IUI patients. Healthy women without
significant medical problems who have a uterine cervix.
EXCLUSION CRITERIA:
- Those with symptoms or signs of infection or are currently menstruating.
- Any medical condition that, in the opinion of Principal Investigator, would preclude
the inclusion of a patient onto this research study.
- Unable or unwilling to give informed consent.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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