Endometrial Nerve Fibers Detection in Patients With Diffe... | NCT01634633

Studies
Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies

NCT01634633

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Jul 6, 2012Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Gynecological Pathologies

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Ain shams maternity hospital	Other Grant/Funding Number	Ain shams maternity hospital

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Nov 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jul 3, 2012

First Submission Date that Met QC Criteria

Jul 5, 2012

First Posted Date

Jul 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2012

Last Update Posted Date

Jul 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevelencce of endometrial nerve fibers	Is to determine the prevelence of endometrial nerve fibers in different gynecological pathologies I via endometrial sampling	18 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Suspected endometriosis.
Patient unwillingness to participate in the study.
No hormonal treatment for the last 6 months.
Suspected pregnancy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed EH Elbohoty, MD	Contact	22590767	00202	elbohoty79@yahoo.com
Karim HI Abd-El-Maeboud, MD	Contact	24140680	+202	kabdelmaeboud@yahoo. com

Overall Officials

Name	Affiliation	Role
Reda MK Ghanem, M.B.B.Ch	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams new maternity hospital	Recruiting	Cairo		11591	Egypt