Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies

July 5, 2012 updated by: reda mokhtar kamal ghanem, Ain Shams Maternity Hospital
The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Recruiting
        • Ain shams new maternity hospital
        • Principal Investigator:
          • Reda MK Ghanem, MD
        • Principal Investigator:
          • Reda MK Ghanem, M.B.B.Ch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic pain
Time Frame: 18 months
Relating the density of endometrial nerve fibres to different types of pelvic pain
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Reda MK Ghanem, M.B.B.Ch, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ENFD-25-2012
  • Ain shams maternity hospital (Other Grant/Funding Number: Ain shams maternity hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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