Protocol Number: 95-CH-0110

Title:

Endometrial Mediators of Gonadal Steroid Action

Number:

95-CH-0110

Summary:

Endometrium is the lining of the uterus. It is where the fertilized egg normally implants during pregnancy.

This study was designed to better understand the way(s) that female sex hormones (estrogen and progesterone) cause the uterus to grow and develop. It is known that these hormones are necessary to prepare the uterus for pregnancy, but the way the hormones work is unknown.

Researchers would like to identify the genes that are affected by female sex hormones by using a variety of tests (in situ hybridization, immunohistochemistry, and culture of human endometrium).

Researchers will select women who have regular monthly menstrual cycles and study them for two cycles;

1. The first cycle (PRE-BIOPSY CYCLE) will include daily measurements of the patient's body temperature and progesterone measurements during the last 14 days (luteal phase) of the menstrual cycle.

2. The second cycle (BIOPSY CYCLE) will include measurements of urinary luteinizing hormone (LH) to determine the day of the LH surge. Luteinizing hormone is the hormone that causes the ovary to release the developed egg. Ovarian ultrasounds will be performed before the biopsy to determine development of the egg. Blood tests will be taken on the day of the biopsy to have an overall idea of the hormones circulating in the patient's blood. An endometrial biopsy will be taken at one of three possible times to identify endometrial products under conditions of estrogen, estrogen/progesterone, or steroid hormone withdrawal.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria:

INCLUSION CRITERIA:

Healthy volunteers will be in excellent health.

Only women with regular menstrual cycles (every 26-35 days) using mechanical (condoms, diaphragm) or sterilization methods of contraception will be included.

Only women with a negative pregnancy test, normal physical examination and laboratory results, and a luteal phase progesterone value of greater than 4 ng/mL will be entered into this study.

Women with endometriosis will be recruited from those with histolgically-proven endometriosis who are participating in protocol 99-CH-0012 or who have endometriosis diagnosed at the time of surgery performed by the gynecology consult service, or under the teaching and training protocol 99-CH-0103.

Special Instructions: Currently Not Provided

Keywords:

Estrogen

Progesterone

Menses

Endometrium

Recruitment Keywords:

Normal Volunteer

Conditions:

Pregnancy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

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

Citations:

A rapid and simple PCR-based method for isolation of cDNA from differentially expressed genes

The clinical evaluation of ovulation and the luteal phase

Midluteal phase endometrial biopsy does not accurately predict luteal function

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004