Association Study Between Periodontal Disease and Male In... | NCT01140945

Studies
Association Study Between Periodontal Disease and Male Infertility

NCT01140945

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Jun 10, 2010Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Periodontitis
Sub-fertility

Interventions

Not provided

Countries

Israel

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

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 9, 2010

First Submission Date that Met QC Criteria

Jun 9, 2010

First Posted Date

Jun 10, 2010Estimated

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

Jun 9, 2010

Last Update Posted Date

Jun 10, 2010Estimated

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 the present study is to examine the association between fertility parameters and the periodontal status of men attending fertility and in vitro fertilization clinic.

Detailed Description

An association has been found between periodontal diseases and preterm low birth weight, coronary heart disease, and cerebral infarction. Anaerobic gram negative bacterial plaque that forms subgingivally is the direct causative factor for the development of Gingivitis and Periodontitis.

However, its possible association with male infertility have not yet been investigated.

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

Not provided

Label	Type	Description	Intervention Names
Males attending in vitro fertilization clinic

Measure	Description	Time Frame
Positive association between periodontitis and infertility

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consent to participate in study

Exclusion Criteria:

Systemic uncontrolled disease

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Males attending in vitro fertiliztion clinic

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah medical organization		Jerusalem		91120	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21443558	Derived	Klinger A, Hain B, Yaffe H, Schonberger O. Periodontal status of males attending an in vitro fertilization clinic. J Clin Periodontol. 2011 Jun;38(6):542-6. doi: 10.1111/j.1600-051X.2011.01720.x. Epub 2011 Mar 28.

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D000091662	Genital Diseases

ID	Term
D010518	Periodontitis
D007246	Infertility