Protocol Number: 09-CH-0180

Title:

Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix

Number:

09-CH-0180

Summary:

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

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria:

INCLUSION CRITERIA

-Female age 18 year or greater who are having regular menstrual cycles and are not on hormonal medications. 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.

Special Instructions:

Currently Not Provided

Keywords:

Cervix

Colposcope

Polarized Light

Cervix Structure

Collagen

Recruitment Keyword(s):

HV

Healthy Volunteer

Healthy Women

Condition(s):

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Maul H, Mackay L, Garfield RE. Cervical ripening: biochemical, molecular, and clinical considerations. Clin Obstet Gynecol. 2006 Sep;49(3):551-63.

KRANTZ KE, PHILLIPS WP. Anatomy of the human uterine cervix, gross and microscopic. Ann N Y Acad Sci. 1962 Sep 29;97:551-63.

Jacques SL, Roman JR, Lee K. Imaging superficial tissues with polarized light. Lasers Surg Med. 2000;26(2):119-29.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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