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.

Condition
Pregnancy

Further Study Details: 

Expected Total Enrollment:  178

Estrogen and progesterone induce characteristic and predictable morphological changes in the endometrium that are required for successful implantation and pregnancy. The mechanism(s) by which estrogen and progesterone exert these effects on the endometrium is not known. We propose to identify genes that are induced by endogenous estrogen and progesterone using in situ hybridization, immunohistochemistry, and culture of human endometrium obtained at hormonally different times of the cycle. Regularly cycling women not at risk for pregnancy will be studied for two menstrual cycles. The first, pre-biopsy cycle, will be characterized by daily basal body temperature measurements and a luteal phase progesterone measurement. During the biopsy cycle, urinary LH measurements will be performed to determine the day of the LH surge. Ovarian ultrasounds to assess follicular development will be performed before biopsy. Blood will be obtained on the day of the biopsy to characterize the hormonal mileau. An endometrial biopsy will be obtained either in the early follicular phase (at a follicular diameter of less than 8 mm), the late follicular phase (follicular diameter greater than 14 mm) or in the mid-(luteal phase day 6-8) or late (luteal phase day 12 - 14) luteal phase, to allow identification of endometrial products under conditions of estrogen, estrogen/progesterone and steroid withdrawal. Alternatively, endometrial tissue may be obtained from normal women and those with endometriosis at the time of menses using a cup-shaped intravaginal collecting device.

Genders Eligible for Study:  Female

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.

Maryland
      National Institute of Child Health and Human Development (NICHD), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  950110; 95-CH-0110
Record last reviewed:  April 30, 2004
Last Updated:  November 23, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001454
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08