Endometrial and Myometrial Changes, With and Without Fibroids

This study has been withdrawn prior to enrollment.
(no enrollment)
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01671215
First received: August 20, 2012
Last updated: April 14, 2015
Last verified: April 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ratio between endometriom & myometrium area, circumference &n volume [ Time Frame: year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01671215     History of Changes
Other Study ID Numbers: MMC120026CTIL
Study First Received: August 20, 2012
Last Updated: April 14, 2015
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 31, 2015