Protocol Number: 09-CH-0085

Title:

Global Study of Women's Health

Number:

09-CH-0085

Summary:

Endometriosis, a condition in which the lining of the uterus grows on nearby tissues, is a common condition that affects women of reproductive age worldwide. The diagnosis of endometriosis is usually made at surgery. The most common symptom is pelvic pain. This pain may occur at the same time as menstrual bleeding, at other times of the cycle, or during or after sexual intercourse. Previous studies reveal the diagnosis of endometriosis is often delayed between 8 and 12 years after the first symptoms. Women with chronic pelvic pain report a lower quality of life. No studies, however, have been conducted to assess whether women with endometriosis-related pelvic pain are affected differently than those with pelvic pain from other or no identifiable causes.

This large-scale study is designed to gather prospective epidemiological data on the impact of and risk factors for endometriosis across countries worldwide. A study of this scale and scope has never been performed; it is anticipated that the study will provide novel insights into the effects of the condition and associated symptoms on women's lives across different countries, as well as explore differences in the effects of various potential risk factors.

This is an international study conducted at more than 20 sites worldwide and coordinated by Oxford University in the United Kingdom. At the National Institutes of Health, 250 premenopausal women between 18 and 45 years of age who are having their first diagnostic laparoscopy or laparoscopy for tubal sterilization will participate. None will have had a prior diagnosis of endometriosis through surgery. Women will be informed about the study when their laparoscopy is scheduled.

Procedures

- Patient completion of an online questionnaire before scheduled surgery. The following will be assessed by the questionnaire:

- Quality of life

- General gynecologic and medical history

- Family history

- General information

- Use of health care services

- Risk factors

- Surgeon completion of questionnaire about surgical findings.

- Follow-up: Women who consent will be contacted every 1-2 years.

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:

A patient who meets all of the following criteria is eligible for the study:

1. Premenopausal female 18 to 45 years of age

2. Attending for her first diagnostic laparoscopy or for laparoscopy for tubal sterilisation

3. Has no previous history of endometriosis diagnosis through surgery

EXCLUSION CRITERIA:

A patient who meets any of the following criteria is ineligible for the study:

1. Already has a surgically-confirmed diagnosis of endometriosis

2. Aged less than18 or greater than 45

3. Aged 18-45 but post-menopausal

Special Instructions:

Currently Not Provided

Keywords:

Endometriosis

Infertility

Tubal Ligation

Chronic Pelvic Pain

Quality of Life

Recruitment Keyword(s):

Endometriosis

Infertility

Chronic Pelvic Pain

Condition(s):

Endometriosis

Infertility

Chronic Pelvic Pain

Tubal Ligation

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): Not Provided

• 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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