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| Tracking Information | |||||
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| First Received Date ICMJE | September 9, 2005 | ||||
| Last Updated Date | September 9, 2005 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Progestin Treatment for Endometrial Stromal Cells in Adenomyosis | ||||
| Official Title ICMJE | |||||
| Brief Summary | Long term treatment of progestin has been demonstrated to have an inhibitory effect on endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result, progestin is now widely employed in the treatment of endometrial cancer, endometrial hyperplasia, and dysfunction uterine bleeding. In the treatment of adenomyosis, however, the beneficial effect of progestin was limited. It might imply that the behavior of endometrial cells in women with adenomyosis is different from that in women without adenomyosis. Our previous study revealed that the expression of killer inhibitory receptors (KIRs) on NK cells was decreased in eutopic endometrium in women with adenomyosis. It may be a compensatory effect in which the NK cytotoxicity is activated in order to wipe out the abnormal endometrial cells that might go out of the eutopic site of endometrium. It implies that the formation of adenomyosis might be due to “abnormal” endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. This finding is compatible with previous reports in which eutopic endometrium obtained from women with endometriosis or adenomyosis was found to behave differently from endometrium in unaffected women. In this study, we try to collect endometrial tissues from women with and without adenomyosis, and then purify the endometrial stromal cells from endometrium. The endometrial stromal cells are cultured for 8 days with the supplement of medroxyprogesterone (MPA) or danazol. Quantification of IL-6 and IL-8 mRNA in endometrial cells, and the concentrations of IL-6 and IL-8 in cultured media will be done with real time RT-PCR and ELISA respectively. The expression of different cytokines of endometrial cells in response to progestin might be further elucidated after our experiment. |
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| Detailed Description | Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group). After becoming pre-confluent (covering 80% of the culture well), ESC was cultured for 8 days solely or with the addition of medroxyprogesterone (MPA) or danazol. ELISA was done to measure IL-6, IL-8, and TNF-alpha concentrations of the culture media. Real-time quantitative RT-PCR was done to measure IL-6, IL-8, and TNF-alpha RNA levels in ESC. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Cross-Sectional, Defined Population, Prospective Study | ||||
| Condition ICMJE | Endometriosis | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 45 | ||||
| Completion Date | April 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 35 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00155051 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 9361700762, NTUH.94S72 | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | June 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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