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Endometrial Changes & Fibroids

This study is not yet open for participant recruitment.
Verified April 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01671215
First received: August 20, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  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
Uterine Malformations

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

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 ]

Estimated Enrollment: 30
Study Start Date: August 2012
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671215

Contacts
Contact: ronni tepper, prof 09-7472872
Contact: yael ganor paz, md yael.ganor@gmail.com

Locations
Israel
Meir medical center Not yet recruiting
Kfar Saba, Israel
Contact: ronni tepper, prof     09-7472872        
Contact: yael ganor paz, md            
Sponsors and Collaborators
Meir Medical Center
  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: August 20, 2012
Health Authority: Israel: Clalit Health Services

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

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

ClinicalTrials.gov processed this record on May 16, 2013