Endometrial Mediators of Gonadal Steroid Action
Colección de datos
Resumen
Fecha de inicio: 21 de abril de 1995
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 129 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 43 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
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 histologically-proven endometriosis. Except for this diagnosis they will meet criteria for healthy volunteers as stated above. Women may participate in the study on more than one occasion, but biopsies may not be performed in a "baseline" cycle.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesAbrir National Institutes of Health Clinical Center, 9000 Rockville Pike en Google Maps