Hormonal Effects on the Uterus and Endometrium
Condition: Pregnancy
Study type: Observational

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. <TAB>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. <TAB> 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.<TAB>
    

Detailed description: 
      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. This is
      a tissue collection protocol to obtain endometrium and/or menstrual effluent from normally
      cycling women, women with endometriosis and women with infertility.

      This tissue will be used for future studies intended to understand gonadal steroid action on
      the endometrium We propose to identify peptides that are induced by endogenous estrogen and
      progesterone using in situ hybridization, immunohistochemistry, microarray analysis and/or
      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. Additionally, women with
      infertility possibly related to endometrial dysfunction will be studied in the luteal phase.
    

Keywords: Estrogen; Progesterone; Menses; Endometrium; Normal Volunteer