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Endometrial and Myometrial Changes, With and Without Fibroids

This study has been withdrawn prior to enrollment.
(no enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671215
First Posted: August 23, 2012
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
fibroids are common among women in fertile age. the relation between fibroids and infertility is controversial. our goal is to claculate a ratio between uterine cavity - endometrium & myometrium in normal uterine s and study the interference of the cavity in uterine s with fibroids.

Condition
Fibroids

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endometrial and Myometrial Changes, With and Without Fibroids

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • ratio between normal & abnormal(by fibroid) uterine cavity [ Time Frame: year ]

Secondary Outcome Measures:
  • ratio between endometriom & myometrium area, circumference &n volume [ Time Frame: year ]

Enrollment: 0
Study Start Date: August 2012
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Detailed Description:

phase 1-

  1. retrospective measurments of uterine dimensions of 100 women with normal uterin
  2. measurment of the above during different sycle days in the same woman. 30 women.

phase 2- retrospective measurments of 500 uterine dimensions of women with fibroids phase 3- the same for 400 uterine malformations

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
women at the age of 20-45
Criteria

Inclusion Criteria:

  • women at IVF unit

Exclusion Criteria:

  • inabilty to measure propperly the uterine dimensions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671215


Locations
Israel
Meir medical center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: ronni tepper, md Tel Aviv University
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01671215     History of Changes
Other Study ID Numbers: MMC120026CTIL
First Submitted: August 20, 2012
First Posted: August 23, 2012
Last Update Posted: April 15, 2015
Last Verified: April 2012

Keywords provided by Meir Medical Center:
endometrium
myometrium
fibroids
uterine malformations

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases