NCT01623063

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

5 months

First QC Date

June 15, 2012

Last Update Submit

June 18, 2012

Conditions

Infertility

Keywords

endometriuminfertilityuterushisteroscopy

Outcome Measures

Primary Outcomes (1)

  • glandular volume

    verify the glandular volume in fertile and infertil patients during the implantation window

    1 month

Secondary Outcomes (1)

  • epitelial surface

    1 month

Study Arms (2)

Infertile

EXPERIMENTAL

patients from our human reproduction center

Procedure: Hysteroscopy

Fertile

ACTIVE COMPARATOR

patients with comproved fertility

Procedure: Hysteroscopy

Interventions

HysteroscopyPROCEDURE

hysteroscopy with guided biopsies

Also known as: Bettocchi system- Karl Storz, pipelle- cornier
FertileInfertile

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 41 years old
  • regular menses
  • infertility over 12 months

You may not qualify if:

  • previous uterine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Dani Ejzenberg

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dani Ejzenberg, MD

CONTACT

55 11 92828550daejz@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 19, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

BR(1)