NCT00155051

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

June 1, 2004

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women with adenomyosis
  • at early- to mid-secretory phases

You may not qualify if:

  • postmenopausal
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jehn-Hsiahn Yang, M.D.

    Department of Obstetrics and Gynecology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jehn-Hsiahn Yang, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

July 1, 2004

Study Completion

April 1, 2005

Last Updated

September 12, 2005

Record last verified: 2004-06

Locations