Histomorphometry Analysis in Fertile and Infertile Patients | NCT01623063

Studies
Histomorphometry Analysis in Fertile and Infertile Patients

NCT01623063

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Jun 19, 2012Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Hysteroscopy

Countries

Brazil

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

Jun 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 2012

Primary Completion Date

Jun 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Jun 15, 2012

First Submission Date that Met QC Criteria

Jun 18, 2012

First Posted Date

Jun 19, 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

Jun 18, 2012

Last Update Posted Date

Jun 19, 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

To detect similarities and differences in the endometrium of fertile and infertile patients

Detailed Description

morphometric and pathologyc analysis of the endometrium in fertile and infertile patients

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infertile	Experimental	patients from our human reproduction center	Procedure: Hysteroscopy
Fertile	Active Comparator	patients with comproved fertility	Procedure: Hysteroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hysteroscopy	Procedure	hysteroscopy with guided biopsies	Fertile Infertile

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
glandular volume	verify the glandular volume in fertile and infertil patients during the implantation window	1 month

Secondary Outcomes

Measure	Description	Time Frame
epitelial surface	to detect differences in the endometrium of fertile and infertile patients	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 41 years old
regular menses
infertility over 12 months

Exclusion Criteria:

previous uterine surgery
use of contraceptive pills or injections less than 3 months from the inclusion in the study

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

41 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dani Ejzenberg, MD	Contact	55 11 92828550		daejz@hotmail.com

Overall Officials

Name	Affiliation	Role
Dani Ejzenberg	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Clinicas	Recruiting	São Paulo	São Paulo	05403000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015907	Hysteroscopy

Ancestor Terms

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided