Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Ain Shams Maternity Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
reda mokhtar kamal ghanem, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01634633
First received: July 3, 2012
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies


Condition
Gynecological Pathologies

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies

Resource links provided by NLM:


Further study details as provided by Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • Prevelencce of endometrial nerve fibers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Is to determine the prevelence of endometrial nerve fibers in different gynecological pathologies I via endometrial sampling


Secondary Outcome Measures:
  • Pelvic pain [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Relating the density of endometrial nerve fibres to different types of pelvic pain


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 3, 2012
Last Updated: July 5, 2012
Health Authority: Egypt ':'

Keywords provided by Ain Shams Maternity Hospital:
Endometrial nerve fibres

ClinicalTrials.gov processed this record on July 20, 2014