Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001454
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
1999-11-03
Brief Title:
Hormonal Effects on the Uterus and Endometrium
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Endometrial Mediators of Gonadal Steroid Action
Status:
COMPLETED
Status Verified Date:
2015-07-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ways 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 TABThe first cycle PRE-BIOPSY CYCLE will include daily measurements of the patients 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 patients blood An endometrial biopsy will be taken at one of three possible times to identify endometrial products under conditions of estrogen estrogenprogesterone or steroid hormone withdrawalTAB
This study was designed to better understand the ways 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 TABThe first cycle PRE-BIOPSY CYCLE will include daily measurements of the patients 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 patients blood An endometrial biopsy will be taken at one of three possible times to identify endometrial products under conditions of estrogen estrogenprogesterone or steroid hormone withdrawalTAB
Detailed Description:
Estrogen and progesterone induce characteristic and predictable morphological changes in the endometrium that are required for successful implantation and pregnancy The mechanisms by which estrogen and progesterone exert these effects on the endometrium is not known This is a tissue collection protocol to obtain endometrium andor 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 andor 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 estrogenprogesterone 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
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 andor 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 estrogenprogesterone 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-CH-0110 | None | None | None |