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Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies

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ClinicalTrials.gov Identifier: NCT01634633
Recruitment Status : Unknown
Verified July 2012 by reda mokhtar kamal ghanem, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : July 6, 2012
Last Update Posted : July 6, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies

Condition or disease
Gynecological Pathologies

Detailed Description:
The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies in addition to its relation to chronic pelvic pain

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Cross-Sectional
Official Title: Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies
Study Start Date : January 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Prevelencce of endometrial nerve fibers [ Time Frame: 18 months ]
    Is to determine the prevelence of endometrial nerve fibers in different gynecological pathologies I via endometrial sampling


Secondary Outcome Measures :
  1. Pelvic pain [ Time Frame: 18 months ]
    Relating the density of endometrial nerve fibres to different types of pelvic pain


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population of this study will be 300 patient undergoing laparoscopy or laparotomy for different gynecological diseases namely, polycystic ovarian disease (PCOD), ovarian cysts either benign or malignant, fibroid uterus, adenomyosis, endometrial hyperplasia and endometrial carcinoma
Criteria

Inclusion Criteria:

  1. Age: 20-60 years of age.
  2. Written and signed informed consent by the patient to participate in the study.
  3. Women candidate for surgical intervention either via laparoscopy or laparotomy for different gynecological pathologies

Exclusion Criteria:

  1. Suspected endometriosis.
  2. Patient unwillingness to participate in the study.
  3. No hormonal treatment for the last 6 months.
  4. Suspected pregnancy.
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): NCT01634633


Contacts
Contact: Ahmed EH Elbohoty, MD 22590767 ext 00202 elbohoty79@yahoo.com
Contact: Karim HI Abd-El-Maeboud, MD 24140680 ext +202 kabdelmaeboud@yahoo. com

Locations
Egypt
Ain shams new maternity hospital Recruiting
Cairo, Egypt, 11591
Principal Investigator: Reda MK Ghanem, MD         
Principal Investigator: Reda MK Ghanem, M.B.B.Ch         
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
Principal Investigator: Reda MK Ghanem, M.B.B.Ch Ain Shams University
More Information

Responsible Party: reda mokhtar kamal ghanem, Mr, Ain Shams University
ClinicalTrials.gov Identifier: NCT01634633     History of Changes
Other Study ID Numbers: ENFD-25-2012
Ain shams maternity hospital ( Other Grant/Funding Number: Ain shams maternity hospital )
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by reda mokhtar kamal ghanem, Ain Shams University:
Endometrial nerve fibres